FDA 510(k)

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

K-Number: K053518 · 2006-01-26

ApplicantMedical Device Technologies, Inc.

Decision Date2006-01-26

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K053518. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR?

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K053518.

When did INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR receive FDA 510(k) clearance?

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR received FDA 510(k) clearance on 2006-01-26, under 510(k) number K053518.

Who is the listed applicant for INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR?

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

What is the FDA product code for INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR?

The FDA product code for INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR is NEU.

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Other records listing Medical Device Technologies, Inc. as applicant

K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT K051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR K050873CANALIZER HYDROPHILIC GUIDE WIRE K043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE K042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT K040427FIBREX CATHETER PATENCY DEVICE

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Official Source

View on FDA Database →

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