Cleared Special

K060655 - SCOUTPRO 8F

Also marketed or referenced as:
HEMOSTATIC VALVE, MODELS 345 968 HOOK GUIDING CATHETER, MODELS 342 263 MULTI-PURPOSE H

K060655 is the FDA 510(k) clearance for SCOUTPRO 8F by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 22-day FDA review.

K060655 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
22d
Days
Class 2
Risk

K060655 is an FDA 510(k) clearance for the SCOUTPRO 8F, MODELS 342 262. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 4, 2006 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K060655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2006
Decision Date April 04, 2006
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K060655.
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
K053491 · Penumbra, Inc. · Apr 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
K060807 · Biotronik, Inc. · Apr 2006
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
K060327 · Vascular Solutions, Inc. · Apr 2006
8F SHERPA NX GUIDE CATHETER
K060418 · Medtronic Vascular · Mar 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572 · Boston Scientific Corporation · Mar 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
K053217 · St Jude Medical · Mar 2006