Cleared Traditional

INTRODUCER, PERCUTANEOUS (K900658) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900658 · Novoste Puerto Rico, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
195d
Days
Class 2
Risk

K900658 is an FDA 510(k) clearance for the INTRODUCER, PERCUTANEOUS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Novoste Puerto Rico, Inc. (Aguadilla, Puerto Rico, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 195 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 Novoste Puerto Rico, Inc. devices

Submission Details

510(k) Number K900658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date August 23, 1990
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K900658.
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · Cordis Corp. · Apr 1991
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · Datascope Corp. · Oct 1990
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · Medtronic Vascular · Aug 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · Datascope Corp. · Jun 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · C.R. Bard, Inc. · May 1990
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · C.R. Bard, Inc. · Mar 1990