Cleared Traditional

K000313 - TEARAWAY INTRODUCER SHEATH

K000313 is an FDA 510(k) clearance for TEARAWAY INTRODUCER SHEATH, manufactured by Xentek Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K000313 · Xentek Medical, Inc. · Cardiovascular device
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Jun 2000
Decision
136d
Days
Class 2
Risk

K000313 is an FDA 510(k) clearance for the TEARAWAY INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Xentek Medical, Inc. (Athens, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 136 days - within the typical 510(k) review window.

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 Xentek Medical, Inc. devices

FDA 510(k) Submission Details - K000313

510(k) Number K000313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date June 16, 2000
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
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 599
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K000313.
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · Terumo Medical Corp. · Nov 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · Datascope Corp. · Aug 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · St. Jude Medical, Inc. · May 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
K992668 · Innerdyne, Inc. · May 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
K001346 · St. Jude Medical, Inc. · May 2000