Cleared Special

K060902 - STARCLOSE INTRODUCER SET MODEL- 1002

K060902 is an FDA 510(k) clearance for STARCLOSE INTRODUCER SET MODEL- 1002, manufactured by Abbott Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 95-day FDA review.

K060902 · Abbott Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
95d
Days
Class 2
Risk

K060902 is an FDA 510(k) clearance for the STARCLOSE INTRODUCER SET MODEL- 1002. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 95 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060902

510(k) Number K060902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date July 07, 2006
Days to Decision 95 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

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 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K060902.
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AGILIS NXT STEERABLE INTRODUCER
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CAROTID ACCESS KIT
K060666 · Terumo Medical Corp. · Jun 2006
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
K053400 · Acumen Medical, Inc. · Jun 2006
INTRODUCER ASSEMBLY WITH ROTATOR LOCK
K060519 · Teleflex Medical · May 2006
K060902 · STARCLOSE INTRODUCER SET MODEL- 1002
Download PDF FDA Summary Abbott Vascular, Inc.