Cleared Traditional

K922484 - COBE SAMPLING SITE

K922484 is an FDA 510(k) clearance for COBE SAMPLING SITE, manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K922484 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
190d
Days
Class 2
Risk

K922484 is an FDA 510(k) clearance for the COBE SAMPLING SITE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K922484

510(k) Number K922484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date December 03, 1992
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K922484.
RETRIEVER 10
K921649 · Target Therapeutics · Mar 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · North American Instrument Corp. · Mar 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101 · Interventional Therapeutics Corp. · Feb 1993
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105 · C.R. Bard, Inc. · Nov 1992
INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
K921845 · Becton Dickinson Vascular Access, Inc. · Nov 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480 · Scimed Life Systems, Inc. · Oct 1992