FDA 510(k)

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS

K-Number: K001965 · 2001-02-02

ApplicantNorth American Medical Products, Inc.

Decision Date2001-02-02

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is North American Medical Products, Inc.. It received FDA 510(k) clearance on 2001-02-02 under 510(k) number K001965. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS?

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is North American Medical Products, Inc.. The 510(k) number is K001965.

When did SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS receive FDA 510(k) clearance?

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS received FDA 510(k) clearance on 2001-02-02, under 510(k) number K001965.

Who is the listed applicant for SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS?

The FDA 510(k) record lists North American Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS?

The FDA product code for SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS is FMI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.