FDA 510(k)

BALLOON CATHETER

K-Number: K810689 · 1981-07-28

Decision Date1981-07-28

Product Code

DecisionSubstantially Equivalent

Device Summary

BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Surgimed Corp.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K810689. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON CATHETER?

BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Surgimed Corp.. The 510(k) number is K810689.

When did BALLOON CATHETER receive FDA 510(k) clearance?

BALLOON CATHETER received FDA 510(k) clearance on 1981-07-28, under 510(k) number K810689.

Who is the listed applicant for BALLOON CATHETER?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgimed Corp. as applicant

K851157SURGIMED - SURGICAL BLADES K840762SILVERTORQUE CEREBRAL CATHETER K840763SILVERTORQUE CARDIAC CATHETERS K840761SILVERTORQUE VISCERAL CATHETER

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.