Cleared Traditional

FIBEROPTIC CATHETER (K880661) - FDA 510(k) Clearance

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

K880661 · Optimed Technologies, Inc. · Cardiovascular device
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May 1988
Decision
75d
Days
Class 2
Risk

K880661 is an FDA 510(k) clearance for the FIBEROPTIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Optimed Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 75 days - a notably fast clearance 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: 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 Optimed Technologies, Inc. devices

Submission Details

510(k) Number K880661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date May 02, 1988
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 153
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K880661.
CATH LAB MONITORING CATHETER
K884065 · C.R. Bard, Inc. · Jan 1989
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986