Cleared Special

K072329 - SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED

K072329 is an FDA 510(k) clearance for SCOUTPRO 8F, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 218-day FDA review.

K072329 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
218d
Days
Class 2
Risk

K072329 is an FDA 510(k) clearance for the SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED. 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 March 25, 2008 after a review of 218 days - an extended review 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. 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 - K072329

510(k) Number K072329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date March 25, 2008
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K072329.
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988 · Biotronik, Inc. · May 2008
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
K080757 · Aga Medical Corp. · Apr 2008
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
K080360 · Endologix, Inc. · Apr 2008
ACUITY UNIVERSAL CUTTER
K080154 · Cardiac Pacemakers, Inc. · Mar 2008
OCCLUSION BALLOON CATHETER
K070126 · Sentreheart, Inc. · Feb 2008
MICROSHEATH XL CATHETERS
K073289 · Flowcardia, Inc. · Jan 2008
K072329 · SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
Download PDF FDA Summary Biotronik, Inc.