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FDA 510(k)

THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES

K-Number: K132645 · 2013-10-04

Decision Date2013-10-04
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2013-10-04 under 510(k) number K132645. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES?

THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES is a medical device that received FDA 510(k) clearance on 2013-10-04. The listed applicant is Medtronic, Inc.. The 510(k) number is K132645.

When did THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES receive FDA 510(k) clearance?

THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES received FDA 510(k) clearance on 2013-10-04, under 510(k) number K132645.

Who is the listed applicant for THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES?

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

What is the FDA product code for THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES?

The FDA product code for THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES is GAD.

Related Clinical Trials

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.

Other records listing Medtronic, Inc. 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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Related Devices (Code: GAD)

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.

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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