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FDA 510(k)

FLEX-TECH BALLOON DILATOR

K-Number: K926038 · 1993-10-25

ApplicantCape Tech Medical Products
Decision Date1993-10-25
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEX-TECH BALLOON DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cape Tech Medical Products. It received FDA 510(k) clearance on 1993-10-25 under 510(k) number K926038. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX-TECH BALLOON DILATOR?

FLEX-TECH BALLOON DILATOR is a medical device that received FDA 510(k) clearance on 1993-10-25. The listed applicant is Cape Tech Medical Products. The 510(k) number is K926038.

When did FLEX-TECH BALLOON DILATOR receive FDA 510(k) clearance?

FLEX-TECH BALLOON DILATOR received FDA 510(k) clearance on 1993-10-25, under 510(k) number K926038.

Who is the listed applicant for FLEX-TECH BALLOON DILATOR?

The FDA 510(k) record lists Cape Tech Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEX-TECH BALLOON DILATOR?

The FDA product code for FLEX-TECH BALLOON DILATOR is KNQ.

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 Cape Tech Medical Products 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.

K926039GUIDE-TECH ENCAPSULATED GUIDEWIREK926040HELI-TECH RETRIEVAL BASKET

Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific Corp

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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