Identity
- Trade Name
- Convey FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. No(0) Side Holes in the Tip Section. FDA UDI
- Model / Reference
- 8F Convey JL3 FDA UDI
- Description
- The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. No(0) Side Holes in the Tip Section. FDA UDI
Identifiers
- Catalog Number
- H749392666600 FDA UDI
- Primary DI / UDI-DI
- 08714729852896 FDA UDI
- 510(k) Number
- K132197 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Centimeter FDA UDI
Category: Vascular guide-catheter, single-use
Convey by Pendracare International, B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guide-catheter, single-use.
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- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
- 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
K132197 also covers:
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
- Convey — Pendracare International, B.V.
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
- Pendracare International, B.V.
Sources (1)
- FDA UDI 36419c23-6500-40e2-9956-3559a45d8b0d 38 fields · synced Jun 1, 2026