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FDA 510(k)

TARGET THERAPEUTICS RADIOPAQUE STYLET

K-Number: K914001 · 1991-11-22

ApplicantTarget Therapeutics
Decision Date1991-11-22
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TARGET THERAPEUTICS RADIOPAQUE STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914001. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TARGET THERAPEUTICS RADIOPAQUE STYLET?

TARGET THERAPEUTICS RADIOPAQUE STYLET is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Target Therapeutics. The 510(k) number is K914001.

When did TARGET THERAPEUTICS RADIOPAQUE STYLET receive FDA 510(k) clearance?

TARGET THERAPEUTICS RADIOPAQUE STYLET received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914001.

Who is the listed applicant for TARGET THERAPEUTICS RADIOPAQUE STYLET?

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

What is the FDA product code for TARGET THERAPEUTICS RADIOPAQUE STYLET?

The FDA product code for TARGET THERAPEUTICS RADIOPAQUE STYLET is DRB.

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Other records listing Target Therapeutics as applicant

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K965071DETACHABLE SLICONE BALLOON (DSB)K964488DETACHABLE SILICONE BALLOON (DSB)K964210RETRIEVER IIK971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCEK965189SPINNAKERK964112BERENSTEIN COIL

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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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