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FDA 510(k)

DETACHABLE SLICONE BALLOON (DSB)

K-Number: K965071 · 1998-04-21

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

Device Summary

DETACHABLE SLICONE 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 K965071. 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 SLICONE BALLOON (DSB)?

DETACHABLE SLICONE 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 K965071.

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

DETACHABLE SLICONE BALLOON (DSB) received FDA 510(k) clearance on 1998-04-21, under 510(k) number K965071.

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

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K964488DETACHABLE SILICONE 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.

K964488DETACHABLE SILICONE BALLOON (DSB)Target Therapeutics

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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