Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, non-electrical FDA UDI
- Device Name
- Reverse Berman Angiographic Balloon Catheter FDA UDI
- Model / Reference
- IPN917243 FDA UDI
- Description
- Reverse Berman Angiographic Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- AI-07035 FDA UDI
- Primary DI / UDI-DI
- 10801902180855 FDA UDI
- 510(k) Number
- K892530 FDA UDI
- FDA Product Code
- DYG FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, non-electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1240 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
Yes
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
Dimensions & Sizes
- Size
- Length — 80 Centimeter FDA UDICatheter Gauge — 5 French FDA UDI
Category: Pulmonary artery balloon catheter, non-electrical
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary artery balloon catheter, non-electrical.
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Cleared under the same submission
K892530 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI ee310c80-b003-4826-accd-94d35be7db87 38 fields · synced Jun 8, 2026