Cleared Traditional

K905698 - CORDIS OPTA 5

K905698 is an FDA 510(k) clearance for CORDIS OPTA 5, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K905698 · Cordis Corp. · Cardiovascular device
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Jul 1991
Decision
201d
Days
Class 2
Risk

K905698 is an FDA 510(k) clearance for the CORDIS OPTA 5. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 201 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K905698

510(k) Number K905698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1990
Decision Date July 09, 1991
Days to Decision 201 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
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K905698.
OPTI-PLAST 5F PTA CATHETERS
K913112 · Vas-Cath, Inc. · Aug 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K912984 · Vas-Cath, Inc. · Aug 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · Scimed Life Systems, Inc. · Aug 1991
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE
K911639 · Vas-Cath, Inc. · Jun 1991
HEMOSTATIC Y CONNECTOR
K911130 · Thomas Medical Products, Inc. · Jun 1991
GESCO PER-Q-CATH NEEDLE
K911215 · Gesco Intl., Inc. · Jun 1991