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FDA 510(k)

TRANS-CATHETER EXTRACTOR

K-Number: K063048 · 2007-09-14

ApplicantTran Pa-C, Inc.
Decision Date2007-09-14
Product CodeODY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRANS-CATHETER EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Tran Pa-C, Inc.. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K063048. The device is classified under product code ODY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS-CATHETER EXTRACTOR?

TRANS-CATHETER EXTRACTOR is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Tran Pa-C, Inc.. The 510(k) number is K063048.

When did TRANS-CATHETER EXTRACTOR receive FDA 510(k) clearance?

TRANS-CATHETER EXTRACTOR received FDA 510(k) clearance on 2007-09-14, under 510(k) number K063048.

Who is the listed applicant for TRANS-CATHETER EXTRACTOR?

The FDA 510(k) record lists Tran Pa-C, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS-CATHETER EXTRACTOR?

The FDA product code for TRANS-CATHETER EXTRACTOR is ODY.

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Related Devices (Code: ODY)

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.

K12226314.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USESymmetry Medical

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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