Catapult Guide Sheath
by Contract Medical International GmbH 2 variants
510(k) K221914
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221914 | Date29 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K221914
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYB
- FDA applicant
- Contract Medical International, GmbH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Catapult Guide Sheath is a catheter introducer device designed for peripheral endovascular procedures. It features an atraumatic tip with smooth transitions from sheath-dilator to dilator-wire, and a kink and crush-resistant shaft that provides excellent pushability.
The device is available in various tip configurations, French sizes, and lengths. It is a Class II medical device with product codes DYB and DRE, and has received FDA 510(k) clearance under regulation number 21 CFR 870.1340.
Devices cleared under K221914
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Catapult Guide Sheath | US-35045-F-HS-H / 5F, 45cm, Hockey stick, hydrophilic coated | 04251244502058 | Length 45 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath | US-35045-F-MP-H / 5F, 45cm, Multipurpose, hydrophilic coated | 04251244502034 | Length 45 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath | US-36045-F-HS-H / 6F, 45cm, Hockey stick, hydrophilic coated | 04251244502133 | Length 45 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath | US-36045-F-MP-H / 6F, 45cm, Multipurpose, hydrophilic coated | 04251244502102 | Length 45 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath | US-36090-F-HS-H / 6F, 90cm, Hockey stick, hydrophilic coated | 04251244502188 | Length 90 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath | US-36090-F-MP-H / 6F, 90cm, Multipurpose, hydrophilic coated | 04251244502164 | Length 90 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath | US-37045-F-HS-H / 7F, 45cm, Hockey stick, hydrophilic coated | 04251244502249 | Length 45 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath | US-37045-F-MP-H / 7F, 45cm, Multipurpose, hydrophilic coated | 04251244502218 | Length 45 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath | US-37090-F-HS-H / 7F, 90cm, Hockey stick, hydrophilic coated | 04251244502287 | Length 90 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath | US-37090-F-MP-H / 7F, 90cm, Multipurpose, hydrophilic coated | 04251244502270 | Length 90 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 4F, 15cm, straight, hydrophilic coated | US-34015-F-ST-H / 4F, 15cm, straight, hydrophilic coated | 04251244501976 | Length 15 cm; Catheter Inner Diameter 1.60 mm | On the market |
| Catapult Guide Sheath 4F, 45cm, straight, hydrophilic coated | US-34045-F-ST-H / 4F, 45cm, straight, hydrophilic coated | 04251244501983 | Length 45 cm; Catheter Inner Diameter 1.60 mm | On the market |
| Catapult Guide Sheath 4F, 60cm, straight, hydrophilic coated | US-34060-F-ST-H / 4F, 60cm, straight, hydrophilic coated | 04251244501990 | Length 60 cm; Catheter Inner Diameter 1.60 mm | On the market |
| Catapult Guide Sheath 4F, 90cm, straight, hydrophilic coated | US-34090-F-ST-H / 4F, 90cm, straight, hydrophilic coated | 04251244502003 | Length 90 cm; Catheter Inner Diameter 1.60 mm | On the market |
| Catapult Guide Sheath 5F, 15cm, straight, hydrophilic coated | US-35015-F-ST-H / 5F, 15cm, straight, hydrophilic coated | 04251244502010 | Length 15 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath 5F, 45cm, RDC, hydrophilic coated | US-35045-F-RDC-H / 5F, 45cm, RDC, hydrophilic coated | 04251244502041 | Length 45 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath 5F, 45cm, straight, hydrophilic coated | US-35045-F-ST-H / 5F, 45cm, straight, hydrophilic coated | 04251244502027 | Length 45 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath 5F, 60cm, straight, hydrophilic coated | US-35060-F-ST-H / 5F, 60cm, straight, hydrophilic coated | 04251244502065 | Length 60 cm; Catheter Inner Diameter 1.92 mm | On the market |
| Catapult Guide Sheath 5F, 90cm, straight, hydrophilic coated | US-35090-F-ST-H / 5F, 90cm, straight, hydrophilic coated | 04251244502072 | Length 90 cm; Catheter Inner Diameter 1.92 cm | On the market |
| Catapult Guide Sheath 6F, 15cm, straight, hydrophilic coated | US-36015-F-ST-H / 6F, 15cm, straight, hydrophilic coated | 04251244502089 | Length 15 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 45cm, LIMA, hydrophilic coated | US-36045-F-LIMA-H / 6F, 45cm, LIMA, hydrophilic coated | 04251244502119 | Length 45 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 45cm, RDC, hydrophilic coated | US-36045-F-RDC-H / 6F, 45cm, RDC, hydrophilic coated | 04251244502126 | Length 45 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 45cm, straight, hydrophilic coated | US-36045-F-ST-H / 6F, 45cm, straight, hydrophilic coated | 04251244502096 | Length 45 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 60cm, straight, hydrophilic coated | US-36060-F-ST-H / 6F, 60cm, straight, hydrophilic coated | 04251244502140 | Length 60 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 90cm, RDC, hydrophilic coated | US-36090-F-RDC-H / 6F, 90cm, RDC, hydrophilic coated | 04251244502171 | Length 90 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 6F, 90cm, straight, hydrophilic coated | US-36090-F-ST-H / 6F, 90cm, straight, hydrophilic coated | 04251244502157 | Length 90 cm; Catheter Inner Diameter 2.25 mm | On the market |
| Catapult Guide Sheath 7F, 15cm, straight, hydrophilic coated | US-37015-F-ST-H / 7F, 15cm, straight, hydrophilic coated | 04251244502195 | Length 15 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 7F, 45cm, LIMA, hydrophilic coated | US-37045-F-LIMA-H / 7F, 45cm, LIMA, hydrophilic coated | 04251244502225 | Length 45 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 7F, 45cm, RDC, hydrophilic coated | US-37045-F-RDC-H / 7F, 45cm, RDC, hydrophilic coated | 04251244502232 | Length 45 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 7F, 45cm, straight, hydrophilic coated | US-37045-F-ST-H / 7F, 45cm, straight, hydrophilic coated | 04251244502201 | Length 45 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 7F, 60cm, straight, hydrophilic coated | US-37060-F-ST-H / 7F, 60cm, straight, hydrophilic coated | 04251244502256 | Length 60 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 7F, 90cm, straight, hydrophilic coated | US-37090-F-ST-H / 7F, 90cm, straight, hydrophilic coated | 04251244502263 | Length 90 cm; Catheter Inner Diameter 2.55 mm | On the market |
| Catapult Guide Sheath 8F, 15cm, straight, hydrophilic coated | US-38015-F-ST-H / 8F, 15cm, straight, hydrophilic coated | 04251244502294 | Length 15 cm; Catheter Inner Diameter 2.88 mm | On the market |
| Catapult Guide Sheath 8F, 45cm, straight, hydrophilic coated | US-38045-F-ST-H / 8F, 45cm, straight, hydrophilic coated | 04251244502300 | Length 45 cm; Catheter Inner Diameter 2.88 mm | On the market |
| Catapult Guide Sheath 8F, 60cm, straight, hydrophilic coated | US-38060-F-ST-H / 8F, 60cm, straight, hydrophilic coated | 04251244502317 | Length 60 cm; Catheter Inner Diameter 2.88 mm | On the market |
| Catapult Guide Sheath 8F, 90cm, straight, hydrophilic coated | US-38090-F-ST-H / 8F, 90cm, straight, hydrophilic coated | 04251244502324 | Length 90 cm; Catheter Inner Diameter 2.88 mm | On the market |
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