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FDA 510(k)

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

K-Number: K130736 · 2013-12-17

ApplicantHelix Medical, LLC
Decision Date2013-12-17
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, LLC. It received FDA 510(k) clearance on 2013-12-17 under 510(k) number K130736. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS?

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is Helix Medical, LLC. The 510(k) number is K130736.

When did BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS receive FDA 510(k) clearance?

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS received FDA 510(k) clearance on 2013-12-17, under 510(k) number K130736.

Who is the listed applicant for BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS?

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

What is the FDA product code for BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS?

The FDA product code for BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS is LRC.

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Other records listing Helix Medical, LLC 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.

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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.

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