Cleared Traditional

K911130 - HEMOSTATIC Y CONNECTOR

K911130 is the FDA 510(k) clearance for HEMOSTATIC Y CONNECTOR by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K911130 · Thomas Medical Products, Inc. · Cardiovascular device
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Jun 1991
Decision
84d
Days
Class 2
Risk

K911130 is an FDA 510(k) clearance for the HEMOSTATIC Y CONNECTOR. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. 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 Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K911130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1991
Decision Date June 06, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 225
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K911130.
BARD PERIPHERAL BALLOON DILATATION CATHETER
K910822 · C.R. Bard, Inc. · Aug 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · Scimed Life Systems, Inc. · Aug 1991
CORDIS OPTA 5
K905698 · Cordis Corp. · Jul 1991
STEALTH CATHETER SYSTEM
K911089 · Target Therapeutics · May 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · Boston Scientific Corp · Apr 1991
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991