Cleared Traditional

K874815 - TARGET THERAPEUTICS STERILE PRODUCTS

K874815 is an FDA 510(k) clearance for TARGET THERAPEUTICS STERILE PRODUCTS, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K874815 · Target Therapeutics · Cardiovascular device
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Feb 1988
Decision
77d
Days
Class 2
Risk

K874815 is an FDA 510(k) clearance for the TARGET THERAPEUTICS STERILE PRODUCTS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 77 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.

FDA 510(k) Submission Details - K874815

510(k) Number K874815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1987
Decision Date February 05, 1988
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 500
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K874815.
FIBEROPTIC CATHETER
K880661 · Optimed Technologies, Inc. · May 1988
MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
K875325 · Schneider-Shilley (Usa) · Feb 1988
MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER
K875326 · Schneider-Shilley (Usa) · Feb 1988
ANGIO WASTE FLUIDS DUMP BAG
K874037 · Procedure Products, Inc. · Jan 1988
MICRO-GUIDE
K870700 · Catheter Research C/O Burditt, Bowles & Radzius · Dec 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
K874815 · TARGET THERAPEUTICS STERILE PRODUCTS
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