Baylis Med Tech Passport Steerable Sheath
FDA UDIClass II (US FDA UDI)
by Oscor Inc.
Identity
- Trade Name
- Baylis Med Tech Passport Steerable Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Passport Steerable Sheath 8.5F FDA UDI
- Model / Reference
- PSS0855517 FDA UDI
- Description
- Passport Steerable Sheath 8.5F FDA UDI
Identifiers
- Catalog Number
- PSS0855517 FDA UDI
- Primary DI / UDI-DI
- 00885672012601 FDA UDI
- 510(k) Number
- K140406 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.8 Millimeter FDA UDIOuter Diameter — 4.2 Millimeter FDA UDI
Category: Vascular guide-catheter, single-use
The Baylis Med Tech Passport Steerable Sheath is a flexible, single-use vascular guide-catheter designed for the percutaneous transluminal passage and placement of diagnostic or interventional catheters, leads, needles, or guidewires through the vascular system. This sheath features a range of preformed shapes, including straight and hockey stick designs, making it suitable for various patient needs.
Similar devices
Also classified as Vascular guide-catheter, single-use.
- Launcher — MEDTRONIC, INC. · Class II
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- SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Cleared under the same submission
K140406 also covers:
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Baylis Med Tech Passport Steerable Sheath — Oscor Inc.
- Destino Twist Steerable Guiding Sheath — Oscor Inc.
- Destino Twist Steerable Guiding Sheath — Oscor Inc.
- Destino Twist Steerable Guiding Sheath — Oscor Inc.
- Destino Twist Steerable Guiding Sheath — Oscor Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI b95f1f59-4c37-4ad7-b849-4058beb6ce8b 37 fields · synced Aug 2, 2026