Cleared Traditional

K881158 - VASCULAR CLAMP

K881158 is an FDA 510(k) clearance for VASCULAR CLAMP, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K881158 · T. Korossurgical Instruments Corp. · Cardiovascular device
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Jun 1988
Decision
94d
Days
Class 2
Risk

K881158 is an FDA 510(k) clearance for the VASCULAR CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on June 20, 1988 after a review of 94 days - within the typical 510(k) review window.

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 T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K881158

510(k) Number K881158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date June 20, 1988
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 66
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K881158.
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
OCCLUSION BALLON CATHETER MODIFICAION
K921399 · Interventional Therapeutics Corp. · Sep 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
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