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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 6.5F FDA UDI
- Model / Reference
- PSS0655517 FDA UDI
- Description
- Passport Steerable Sheath 6.5F FDA UDI
Identifiers
- Catalog Number
- PSS0655517 FDA UDI
- Primary DI / UDI-DI
- 00885672012526 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.2 Millimeter FDA UDIOuter Diameter — 3.1 Millimeter FDA UDI
Category: Vascular guide-catheter, single-use
Baylis Med Tech Passport Steerable Sheath by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
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- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- 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.
- 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.
- Destino Twist Steerable Guiding Sheath — Oscor Inc.
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 |
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Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI 97e57651-1a99-417e-8409-cb75f9e655e0 37 fields · synced May 30, 2026