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SABER .014 PTA Dilatation Catheter
FDA UDIClass II (US FDA UDI)
by Cordis Corp.
Identity
- Trade Name
- SABER .014 PTA Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- PTA, OTW, 4.0 x 300, 150cm FDA UDI
- Model / Reference
- 47040300M FDA UDI
- Description
- PTA, OTW, 4.0 x 300, 150cm FDA UDI
Identifiers
- Catalog Number
- 47040300M FDA UDI
- Primary DI / UDI-DI
- 20705032090114 FDA UDI
- 510(k) Number
- K221832 FDA UDI
- FDA Product Code
- LIT FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
SABER .014 PTA Dilatation Catheter by Cordis Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Cleared under the same submission
K221832 also covers:
- SABER .014 PTA Dilatation Catheter — Cordis Corp.
- SABER .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
- SABERX .014 PTA Dilatation Catheter — Cordis Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cordis Corp.
Sources (1)
- FDA UDI 18e48611-4e84-43a4-9bfb-647fdbb534fd 35 fields · synced May 30, 2026