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FDA 510(k)

TM MICRO-CATHETERS

K-Number: K971124 · 1997-05-16

ApplicantXomed, Inc.
Decision Date1997-05-16
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TM MICRO-CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1997-05-16 under 510(k) number K971124. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TM MICRO-CATHETERS?

TM MICRO-CATHETERS is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Xomed, Inc.. The 510(k) number is K971124.

When did TM MICRO-CATHETERS receive FDA 510(k) clearance?

TM MICRO-CATHETERS received FDA 510(k) clearance on 1997-05-16, under 510(k) number K971124.

Who is the listed applicant for TM MICRO-CATHETERS?

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

What is the FDA product code for TM MICRO-CATHETERS?

The FDA product code for TM MICRO-CATHETERS is ETD.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: ETD)

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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