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FDA 510(k)

DILATATION CATHETER, BALLOON

K-Number: K952968 · 1995-08-10

ApplicantBoston Scientific Corp
Decision Date1995-08-10
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

DILATATION CATHETER, BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1995-08-10 under 510(k) number K952968. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILATATION CATHETER, BALLOON?

DILATATION CATHETER, BALLOON is a medical device that received FDA 510(k) clearance on 1995-08-10. The listed applicant is Boston Scientific Corp. The 510(k) number is K952968.

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

DILATATION CATHETER, BALLOON received FDA 510(k) clearance on 1995-08-10, under 510(k) number K952968.

Who is the listed applicant for DILATATION CATHETER, BALLOON?

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

What is the FDA product code for DILATATION CATHETER, BALLOON?

The FDA product code for DILATATION CATHETER, BALLOON is LJE.

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Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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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