Cleared Traditional

K933236 - CORDIS OPTA 5(TM)

K933236 is an FDA 510(k) clearance for CORDIS OPTA 5(TM), 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 207-day FDA review.

K933236 · Cordis Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 1993
Decision
207d
Days
Class 2
Risk

K933236 is an FDA 510(k) clearance for the CORDIS OPTA 5(TM), MODIFICATION. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 207 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 - K933236

510(k) Number K933236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date December 27, 1993
Days to Decision 207 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
82d slower than avg
Panel avg: 125d · This submission: 207d
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 K933236.
VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER
K925485 · Vas-Cath, Inc. · Mar 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · Scimed Life Systems, Inc. · Jan 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1994
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · NuMED, Inc. · Dec 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · Boston Scientific Corp · Dec 1993
SCIMED MAVERICK PTA CATHETER
K932537 · Scimed Life Systems, Inc. · Dec 1993