Cleared Traditional

K870067 - MULTICATH - CODE#S 8.1207.OO/8.1208.00/...

K870067 is an FDA 510(k) clearance for MULTICATH - CODE#S 8.1207.OO/8.1208.00/..., manufactured by Vygon Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K870067 · Vygon Corp. · Cardiovascular device
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Apr 1987
Decision
110d
Days
Class 2
Risk

K870067 is an FDA 510(k) clearance for the MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on April 28, 1987 after a review of 110 days - within the typical 510(k) review window.

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 Vygon Corp. devices

FDA 510(k) Submission Details - K870067

510(k) Number K870067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date April 28, 1987
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 620
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K870067.
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