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FDA 510(k)

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

K-Number: K960766 · 1997-03-19

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1997-03-19
Product CodeDYF
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K960766. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT?

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K960766.

When did MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT receive FDA 510(k) clearance?

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT received FDA 510(k) clearance on 1997-03-19, under 510(k) number K960766.

Who is the listed applicant for MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT?

The FDA product code for MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT is DYF.

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Other records listing Meadox Medicals, Div. Boston Scientific Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGK962433MEADOX EXXCEL EPTFE VASCULAR GRAFTK961847HEMASHIELD VANTAGE (VASCULAR GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFTK952884NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

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Related Devices (Code: DYF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSImpra, Inc.K000504ADVANTA SUPER SOFT GRAFTAtrium Medical Corp.K992958ADVANTA GRAFT (<6MM)Atrium Medical Corp.K991683PTFE RINGED GORE-TEX VASCULAR GRAFTW. L. Gore & Associates, Inc.K992441ADVANTA GRAFTAtrium Medical Corp.K984183PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451Possis Medical, Inc.

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.

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