Cleared Traditional

K852479 - PULMONARY VEIN CLAMP

K852479 is an FDA 510(k) clearance for PULMONARY VEIN CLAMP, manufactured by None. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K852479 · None · Cardiovascular device
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Aug 1985
Decision
59d
Days
Class 2
Risk

K852479 is an FDA 510(k) clearance for the PULMONARY VEIN CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by None (San Diego, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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.

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FDA 510(k) Submission Details - K852479

510(k) Number K852479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date August 09, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 180
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K852479.
VASCULAR CLAMP
K881158 · T. Korossurgical Instruments Corp. · Jun 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
MICRO ANASTOMOSIS CLAMP
K861924 · Pilling Co. · Jun 1986
FOGARTY 6MM SOFTJAW CLIP
K832554 · American Edwards Laboratories · Sep 1983
P-S BERLIN VESSEL CLAMP
K820949 · Pudenz-Schulte Medical Research Corp. · Apr 1982
VASCULAR PAWS
K813062 · Sil-Med Corp. · Dec 1981