Cleared Traditional

K960625 - SPREADABLE SHEATH INTRODUCER SET

K960625 is an FDA 510(k) clearance for SPREADABLE SHEATH INTRODUCER SET, manufactured by Neostar Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K960625 · Neostar Medical Technologies, Inc. · Cardiovascular device
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Aug 1996
Decision
177d
Days
Class 2
Risk

K960625 is an FDA 510(k) clearance for the SPREADABLE SHEATH INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Neostar Medical Technologies, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 177 days - an extended review 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: 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 Neostar Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K960625

510(k) Number K960625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date August 08, 1996
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K960625.
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · Cordis Corp. · Oct 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · B.Braun Medical, Inc. · Sep 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · C.R. Bard, Inc. · Aug 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · C.R. Bard, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · B.Braun Medical, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K955820 · B.Braun Medical, Inc. · Mar 1996