Identity
- Trade Name
- Wedge Pressure 6fr 80cm Modified J-tip FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, non-electrical FDA UDI
- Device Name
- Wedge Pressure Balloon Catheter FDA UDI
- Model / Reference
- 162-80P FDA UDI
- Description
- Wedge Pressure Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- 162-80P FDA UDI
- Primary DI / UDI-DI
- M82216280P2 FDA UDI
- 510(k) Number
- K920873 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, non-electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Category: Pulmonary artery balloon catheter, non-electrical
Wedge Pressure 6fr 80cm Modified J-tip by Alpha Medical Instruments Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary artery balloon catheter, non-electrical.
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Cleared under the same submission
K920873 also covers:
- Wedge Pressure 4fr 60cm Modified J-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip) — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 5fr 60cm Modified J-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 6fr 110cm S-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 7fr 110cm S-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 7fr 90cm Modified J-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 6fr 110cm S-tip — ALPHA MEDICAL INSTRUMENTS LLC
- Wedge Pressure 6fr 110cm Standard Tip — ALPHA MEDICAL INSTRUMENTS LLC
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
- Alpha Medical Instruments Llc
Sources (1)
- FDA UDI b10e2117-6079-40f8-a0c3-7a354b93e8e7 37 fields · synced May 30, 2026