Cleared Traditional

K912548 - LEMAITRE-BOOKWALTER VESSEL DEVICES

K912548 is an FDA 510(k) clearance for LEMAITRE-BOOKWALTER VESSEL DEVICES, manufactured by Vascutech, Inc.. The device is a Class 2 Cardiovascular device with product code DWP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K912548 · Vascutech, Inc. · Cardiovascular device
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Sep 1991
Decision
100d
Days
Class 2
Risk

K912548 is an FDA 510(k) clearance for the LEMAITRE-BOOKWALTER VESSEL DEVICES. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Vascutech, Inc. (Andover, US). The FDA issued a Cleared decision on September 18, 1991 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - 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 Vascutech, Inc. devices

FDA 510(k) Submission Details - K912548

510(k) Number K912548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date September 18, 1991
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWP Device Classification - Class 2, Special Controls

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

All 10
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K912548.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · Fehling Surgical Instruments, Inc. · Apr 2023
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
LAPAROSCOPIC VESSEL ARTICULATOR
K911475 · United States Endoscopy Group, Inc. · Jul 1991
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982