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FDA 510(k)

INSCOPE 3-STAGE BALLOON DILATOR

K-Number: K043605 · 2005-02-04

ApplicantCordis Europa, N.V.
Decision Date2005-02-04
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSCOPE 3-STAGE BALLOON DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Europa, N.V.. It received FDA 510(k) clearance on 2005-02-04 under 510(k) number K043605. 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 INSCOPE 3-STAGE BALLOON DILATOR?

INSCOPE 3-STAGE BALLOON DILATOR is a medical device that received FDA 510(k) clearance on 2005-02-04. The listed applicant is Cordis Europa, N.V.. The 510(k) number is K043605.

When did INSCOPE 3-STAGE BALLOON DILATOR receive FDA 510(k) clearance?

INSCOPE 3-STAGE BALLOON DILATOR received FDA 510(k) clearance on 2005-02-04, under 510(k) number K043605.

Who is the listed applicant for INSCOPE 3-STAGE BALLOON DILATOR?

The FDA 510(k) record lists Cordis Europa, N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSCOPE 3-STAGE BALLOON DILATOR?

The FDA product code for INSCOPE 3-STAGE BALLOON DILATOR is KNQ.

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Other records listing Cordis Europa, N.V. 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.

K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETERK063563CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETERK060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDK040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMK032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTAK012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

View all 7 devices →

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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