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FDA 510(k)

PTFE PEEL AWAY MICROINTRODUCER

K-Number: K072130 · 2007-10-31

ApplicantIntromed
Decision Date2007-10-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTFE PEEL AWAY MICROINTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Intromed. It received FDA 510(k) clearance on 2007-10-31 under 510(k) number K072130. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTFE PEEL AWAY MICROINTRODUCER?

PTFE PEEL AWAY MICROINTRODUCER is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Intromed. The 510(k) number is K072130.

When did PTFE PEEL AWAY MICROINTRODUCER receive FDA 510(k) clearance?

PTFE PEEL AWAY MICROINTRODUCER received FDA 510(k) clearance on 2007-10-31, under 510(k) number K072130.

Who is the listed applicant for PTFE PEEL AWAY MICROINTRODUCER?

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

What is the FDA product code for PTFE PEEL AWAY MICROINTRODUCER?

The FDA product code for PTFE PEEL AWAY MICROINTRODUCER is DYB.

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Related Devices (Code: DYB)

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

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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