Cleared Traditional

K935077 - CATH-SEAL

K935077 is the FDA 510(k) clearance for CATH-SEAL by Universal Medical Instrument Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K935077 · Universal Medical Instrument Corp. · Cardiovascular device
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Jun 1994
Decision
228d
Days
Class 2
Risk

K935077 is an FDA 510(k) clearance for the CATH-SEAL. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Ballston Spa, US). The FDA issued a Cleared decision on June 7, 1994 after a review of 228 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K935077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date June 07, 1994
Days to Decision 228 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 393
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K935077.
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · Arrow Intl., Inc. · Nov 1994
URESIL DILATOR
K942191 · Uresil Corp. · Sep 1994
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · Ohmeda Medical · Jul 1994
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · Advanced Cardiovascular Systems, Inc. · Apr 1994
CATHETER INTRODUCER MODIFICATION
K934285 · Daig Corp. · Nov 1993
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993