FDA 510(k)

ADVANTA SST GRAFT (<6MM)

Q: What is the ADVANTA SST GRAFT (<6MM)?

ADVANTA SST GRAFT (<6MM) is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Atrium Medical Corp.. The 510(k) number is K010517.

Q: When did ADVANTA SST GRAFT (<6MM) receive FDA 510(k) clearance?

ADVANTA SST GRAFT (<6MM) received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010517.

Q: Who is the listed applicant for ADVANTA SST GRAFT (<6MM)?

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

Q: What is the FDA product code for ADVANTA SST GRAFT (<6MM)?

The FDA product code for ADVANTA SST GRAFT (<6MM) is DSY.

K-Number: K010517 · 2001-05-18

ApplicantAtrium Medical Corp.

Decision Date2001-05-18

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ADVANTA SST GRAFT (<6MM) 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 2001-05-18 under 510(k) number K010517. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTA SST GRAFT (<6MM)?

ADVANTA SST GRAFT (<6MM) is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Atrium Medical Corp.. The 510(k) number is K010517.

When did ADVANTA SST GRAFT (<6MM) receive FDA 510(k) clearance?

ADVANTA SST GRAFT (<6MM) received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010517.

Who is the listed applicant for ADVANTA SST GRAFT (<6MM)?

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 SST GRAFT (<6MM)?

The FDA product code for ADVANTA SST GRAFT (<6MM) is DSY.

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Other records listing Atrium Medical Corp. as applicant

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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.