Flo-Thru Intraluminal Shunt®

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name: Flo-Thru Intraluminal Shunt® FDA UDI
Generic Name: Surgical intravascular shunt FDA UDI
Device Name: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis. FDA UDI
Model / Reference: FT-12175 FDA UDI
Description: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis. FDA UDI

Identifiers

Catalog Number: FT12175 FDA UDI
Primary DI / UDI-DI: 00085412532462 FDA UDI
510(k) Number: K981624 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Surgical intravascular shunt 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical intravascular shunt

Flo-Thru Intraluminal Shunt® by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical intravascular shunt.

Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC. · Class II
Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC. · Class II
Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC. · Class II
Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC. · Class II
Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC. · Class II
Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC. · Class II

Cleared under the same submission

K981624 also covers:

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: Synovis Life Technologies, Inc.

Sources (1)

FDA UDI a1965bb9-fc0f-4579-b7f9-9ee1395e80c7 36 fields · synced May 30, 2026