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Novasight Hybrid™ Catheter Accessories Package

FDA UDI

Class II (US FDA UDI)

by Conavi Medical Inc

Identity

Trade Name
Novasight Hybrid™ Catheter Accessories Package FDA UDI
Generic Name
Coronary optical coherence tomography system catheter FDA UDI
Device Name
Imaging catheter accessories FDA UDI
Model / Reference
SA-10-0022 FDA UDI
Description
Imaging catheter accessories FDA UDI

Identifiers

Primary DI / UDI-DI
00628055603061 FDA UDI
510(k) Number
K172258 FDA UDI
FDA Product Code
OBJ FDA UDI
NQQ FDA UDI
IYO FDA UDI
GMDN Term
Coronary optical coherence tomography system catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
892.1560 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: Intravascular ultrasound imaging catheter, single-useCoronary optical coherence tomography system catheter

Novasight Hybrid™ Catheter Accessories Package by Conavi Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary optical coherence tomography system catheter.

Cleared under the same submission

K172258 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conavi Medical Inc

Sources (1)

  • FDA UDI 36a16533-455a-426c-8551-1f44d16dde69 35 fields · synced Jun 8, 2026