Reprocessed Femoral Compression Device

FDA 510(k) K012574 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK012574

Submission

Device name
Reprocessed Femoral Compression Device
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
August 9, 2001
Decision date
July 18, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NMF – Clamp, Vascular, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NMF

510(k)DeviceApplicantDecision
K120204Reprocessed Femoral Compression DeviceNMF · Traditional Sterilmed, Inc.04/03/2012SE
K011832Vanguard Reprocessed Femoral Compression DeviceNMF · Traditional Vanguard Medical Concepts, Inc.12/21/2001SE

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Questions and answers

When was Reprocessed Femoral Compression Device cleared by the FDA?

Reprocessed Femoral Compression Device (K012574) received a 510(k) decision of Substantially Equivalent on July 18, 2002, 343 days after the submission was received.

What is the product code of K012574?

The FDA product code is NMF – Clamp, Vascular, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.4450.