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CoAxia FloControl™ Catheter

FDA UDI

Class II (US FDA UDI)

by ZOLL Circulation, Inc.

Identity

Trade Name
CoAxia FloControl™ Catheter FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. FDA UDI
Model / Reference
1028 FDA UDI
Description
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. FDA UDI

Identifiers

Catalog Number
8700-000776-01 FDA UDI
Primary DI / UDI-DI
00849111030014 FDA UDI
510(k) Number
K090970 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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 occluding balloon catheter, image-guided

CoAxia FloControl™ Catheter by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZOLL Circulation, Inc.

Sources (1)

  • FDA UDI 637442dd-ff4c-498a-9ef4-36cb120b31d0 36 fields · synced Jun 9, 2026