Cleared Traditional

K890432 - DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)

K890432 is an FDA 510(k) clearance for DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM), manufactured by Deknatel, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K890432 · Deknatel, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
76d
Days
Class 1
Risk

K890432 is an FDA 510(k) clearance for the DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM). Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Deknatel, Inc. (San Jose-Heredia, CR). The FDA issued a Cleared decision on April 13, 1989 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 Deknatel, Inc. devices

FDA 510(k) Submission Details - K890432

510(k) Number K890432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date April 13, 1989
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 40
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K890432.
INSULATION PAD
K896307 · Bio-Vascular, Inc. · Jan 1990
MODEL 6888 LEAD TUNNELER
K894738 · Cardiac Pacemakers, Inc. · Sep 1989
MODIFIED EXTERNAL PAD
K891000 · Instromedix, Inc. · May 1989
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
K890707 · Dlp, Inc. · Apr 1989
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · Buckman Co., Inc. · Jul 1988
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
K864461 · Medsurg Industries, Inc. · Nov 1986