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FDA 510(k)

DETACHABLE SILICONE BALLOON (DSB)

K-Number: K964488 · 1998-04-21

ApplicantTarget Therapeutics
Decision Date1998-04-21
Product CodeMZQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DETACHABLE SILICONE BALLOON (DSB) is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K964488. The device is classified under product code MZQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETACHABLE SILICONE BALLOON (DSB)?

DETACHABLE SILICONE BALLOON (DSB) is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Target Therapeutics. The 510(k) number is K964488.

When did DETACHABLE SILICONE BALLOON (DSB) receive FDA 510(k) clearance?

DETACHABLE SILICONE BALLOON (DSB) received FDA 510(k) clearance on 1998-04-21, under 510(k) number K964488.

Who is the listed applicant for DETACHABLE SILICONE BALLOON (DSB)?

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 DETACHABLE SILICONE BALLOON (DSB)?

The FDA product code for DETACHABLE SILICONE BALLOON (DSB) is MZQ.

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Other records listing Target Therapeutics 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.

K965071DETACHABLE SLICONE BALLOON (DSB)K964210RETRIEVER IIK971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCEK965189SPINNAKERK964112BERENSTEIN COILK963307GDC PATIENT RETURN ELECTTRODE MODEL 45021

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Related Devices (Code: MZQ)

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.

K965071DETACHABLE SLICONE BALLOON (DSB)Target Therapeutics

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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