Cleared Traditional

K952968 - DILATATION CATHETER

K952968 · Boston Scientific Corp · Gastroenterology & Urology device

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Aug 1995

Decision

44d

Days

Risk

K952968 is an FDA 510(k) clearance for the DILATATION CATHETER, BALLOON. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on August 10, 1995 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number	K952968 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 27, 1995
Decision Date	August 10, 1995
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

86d faster than avg

Panel avg: 130d · This submission: 44d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 45

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K952968.

MANAN GENERAL UTILITY DRAINAGE CATHETER

K953713 · Manan Medical Products, Inc. · Mar 1996

MANAN NEPHROSTOMY DRAINAGE CATHETER

K953547 · Manan Medical Products, Inc. · Aug 1995

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

K952887 · Meadox Medicals, Div. Boston Scientific Corp. · Aug 1995

NEPHRO-URETERAL STENT

K942688 · Uresil Corp. · Jun 1995

MALECOT-NEPHROSTOMY TAMPONADE CATHETER

K915209 · Cook Urological, Inc. · Nov 1992

URESIL SUMP DRAINAGE CATHETER

K920509 · Uresil Corp. · Sep 1992

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K952968

Boston Scientific Corp

Natick,, MA · US

Lorraine M Hanley

Regulatory profile

432 submissions 411 cleared

95% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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