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FDA 510(k)

ADVANTA SUPER SOFT GRAFT

K-Number: K000504 · 2000-03-01

ApplicantAtrium Medical Corp.
Decision Date2000-03-01
Product CodeDYF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANTA SUPER SOFT GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K000504. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTA SUPER SOFT GRAFT?

ADVANTA SUPER SOFT GRAFT is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is Atrium Medical Corp.. The 510(k) number is K000504.

When did ADVANTA SUPER SOFT GRAFT receive FDA 510(k) clearance?

ADVANTA SUPER SOFT GRAFT received FDA 510(k) clearance on 2000-03-01, under 510(k) number K000504.

Who is the listed applicant for ADVANTA SUPER SOFT GRAFT?

The FDA 510(k) record lists Atrium Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTA SUPER SOFT GRAFT?

The FDA product code for ADVANTA SUPER SOFT GRAFT is DYF.

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Other records listing Atrium Medical 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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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.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.K983769DISTAFLO BYPASS GRAFTImpra, 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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