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FDA 510(k)

IMPACT BALLOON DILATION CATHETER

K-Number: K983373 · 1999-06-22

ApplicantB. Braun/Mcgaw
Decision Date1999-06-22
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMPACT BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun/Mcgaw. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K983373. 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 IMPACT BALLOON DILATION CATHETER?

IMPACT BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is B. Braun/Mcgaw. The 510(k) number is K983373.

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

IMPACT BALLOON DILATION CATHETER received FDA 510(k) clearance on 1999-06-22, under 510(k) number K983373.

Who is the listed applicant for IMPACT BALLOON DILATION CATHETER?

The FDA 510(k) record lists B. Braun/Mcgaw as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPACT BALLOON DILATION CATHETER?

The FDA product code for IMPACT BALLOON DILATION CATHETER 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 B. Braun/Mcgaw 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.

K994111CELSITE, MODELS ST401L, ST405L

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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