Cleared Traditional

K792172 - PERCUTANEOUS SHEATH INTRO. KIT OR TRAY

K792172 is an FDA 510(k) clearance for PERCUTANEOUS SHEATH INTRO. KIT OR TRAY, manufactured by Stanco Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K792172 · Stanco Medical, Inc. · Cardiovascular device
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Nov 1979
Decision
15d
Days
Class 2
Risk

K792172 is an FDA 510(k) clearance for the PERCUTANEOUS SHEATH INTRO. KIT OR TRAY. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K792172

510(k) Number K792172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1979
Decision Date November 13, 1979
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 502
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K792172.
TEMPORARY TRANSVENOUS PACMKER. ELECTRODE
K792131 · Stanco Medical, Inc. · Nov 1979
PERCUTANEOUS SHEATH (MULTI-CATH)SIDE
K792170 · Stanco Medical, Inc. · Nov 1979
COMPLETE TRAY CENTRAL VENOUS PRESSURE
K792171 · Stanco Medical, Inc. · Nov 1979
PERMANENT LEAD INTRADUCER
K791129 · Daig Corp. · Jul 1979
CATHETER INTRODUCERS, ARTERISE
K781954 · C.R. Bard, Inc. · Nov 1978
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · Arrow Intl., Inc. · Apr 1978