Cleared Traditional

K935077 - CATH-SEAL

K935077 is an FDA 510(k) clearance for CATH-SEAL, manufactured by Universal Medical Instrument Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K935077

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
Combination Product No
PCCP Authorized No
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.

DYB Device Classification - Class 2, Special Controls

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 606
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K935077.
URESIL DILATOR
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K944107 · Medamicus, Inc. · 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
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
K934901 · Thomas Medical Products, Inc. · Jan 1994
CATHETER INTRODUCER MODIFICATION
K934285 · Daig Corp. · Nov 1993