Cleared Traditional

K973080 - SURGICAL VASCULAR CLAMP

K973080 is an FDA 510(k) clearance for SURGICAL VASCULAR CLAMP, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K973080 · Walter Lorenz Surgical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
189d
Days
Class 2
Risk

K973080 is an FDA 510(k) clearance for the SURGICAL VASCULAR CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 23, 1998 after a review of 189 days - an extended review 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: 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 Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K973080

510(k) Number K973080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date February 23, 1998
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
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 151
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K973080.
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · Boss Instruments, Ltd. · Jun 1998
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
K980898 · Radi Medical Systems AB · Apr 1998
EZ HOLD 1 LBS., EZ HOLD 2 LBS
K973132 · Tz Medical, Inc. · Jan 1998
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
K964663 · Rmds, Inc. · Dec 1997
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
K973216 · Rmds, Inc. · Nov 1997