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Surefire Guiding Catheter

FDA UDI

Class II (US FDA UDI)

by Surefire Medical, Inc.

Identity

Trade Name
Surefire Guiding Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
65cm, 5F Guiding Catheter with Cobra1 Shape FDA UDI
Model / Reference
SGC-5065-Cobra1 FDA UDI
Description
65cm, 5F Guiding Catheter with Cobra1 Shape FDA UDI

Identifiers

Primary DI / UDI-DI
00857136004057 FDA UDI
510(k) Number
K140034 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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
Length — 65 Centimeter FDA UDI
Lumen/Inner Diameter — 0.056 Inch FDA UDI
Catheter Gauge — 5 French FDA UDI

Category: Vascular guide-catheter, single-use

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

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K140034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surefire Medical, Inc.

Sources (1)

  • FDA UDI feda3d4c-b76d-4d61-b17c-2b3dfeb4f3a8 35 fields · synced May 30, 2026