← Back to catalogue

Surefire Infusion System

FDA UDI

Class II (US FDA UDI)

by Surefire Medical, Inc.

Identity

Trade Name
Surefire Infusion System FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Device Name
120cm, 3.8F Microcatheter with 7.5mm Expandable Tip FDA UDI
Model / Reference
SHF-38120-LT FDA UDI
Description
120cm, 3.8F Microcatheter with 7.5mm Expandable Tip FDA UDI

Identifiers

Primary DI / UDI-DI
00857136004019 FDA UDI
510(k) Number
K121677 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter 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

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
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 0.027 Inch FDA UDI
Outer Diameter — 0.051 Inch FDA UDI
Length — 120 Centimeter FDA UDI

Category: Peripheral vascular intervention infusion catheter

Surefire Infusion System by Surefire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular intervention infusion catheter.

Cleared under the same submission

K121677 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Surefire Medical, Inc.

Sources (1)

  • FDA UDI 2f1692d6-cafe-449a-af3f-a4ef9fa62fd8 35 fields · synced May 30, 2026