Identity
- Trade Name
- ACIST Navvus® Catheter FDA UDI
- Generic Name
- Catheter-tip transducer, pressure FDA UDI
- Device Name
- Navvus Catheter, p/n 701481-010 FDA UDI
- Model / Reference
- 014667 FDA UDI
- Description
- Navvus Catheter, p/n 701481-010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716101240 FDA UDI
- 510(k) Number
- K132474 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Catheter-tip transducer, pressure FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2870 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
Category: Catheter-tip transducer, pressure
ACIST Navvus® Catheter by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter-tip transducer, pressure.
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- PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
- PressureWire™ — LIGHTLAB IMAGING, INC. · Class II
- PrimeWire Prestige Pressure Guide Wire 185cm ST — Volcarica S.R.L. · Class II
Cleared under the same submission
K132474 also covers:
- ACIST RXi® Ao Interface Box — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, 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
- ACIST Medical Systems, Inc.
Sources (1)
- FDA UDI bdff929e-603d-4848-ac25-7806fd52cd62 35 fields · synced Jun 8, 2026