Cleared Traditional

K770503 - LOUISVILLE CLAMP PRODUCT #65-172

K770503 is an FDA 510(k) clearance for LOUISVILLE CLAMP PRODUCT #65-172, manufactured by Edward Weck, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K770503 · Edward Weck, Inc. · Cardiovascular device
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Mar 1977
Decision
14d
Days
Class 2
Risk

K770503 is an FDA 510(k) clearance for the LOUISVILLE CLAMP PRODUCT #65-172. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1977 after a review of 14 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.

View all Edward Weck, Inc. devices

FDA 510(k) Submission Details - K770503

510(k) Number K770503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1977
Decision Date March 30, 1977
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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.