Cleared Traditional

K853100 - COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT

K853100 is the FDA 510(k) clearance for COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT by Cobe Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K853100 · Cobe Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
64d
Days
Class 2
Risk

K853100 is an FDA 510(k) clearance for the COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 25, 1985 after a review of 64 days - a notably fast clearance 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: 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K853100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date September 25, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 318
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K853100.
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · Telectronics, Inc. · Jul 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · Telectronics, Inc. · Jul 1985