Cleared Special

K010853 - GUIDER SOFTIP GUIDING CATHETER XF 5F

K010853 is an FDA 510(k) clearance for GUIDER SOFTIP GUIDING CATHETER XF 5F, manufactured by Boston Scientific, Target. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 28-day FDA review.

K010853 · Boston Scientific, Target · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
28d
Days
Class 2
Risk

K010853 is an FDA 510(k) clearance for the GUIDER SOFTIP GUIDING CATHETER XF 5F. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on April 18, 2001 after a review of 28 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 Boston Scientific, Target devices

FDA 510(k) Submission Details - K010853

510(k) Number K010853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2001
Decision Date April 18, 2001
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 651
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K010853.
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
K003880 · Concentric Medical, Inc. · May 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · NuMED, Inc. · Apr 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · Intra Luminal Therapeutics, Inc. · Apr 2001
SUPERCROSS CATHETER
K001856 · Abbott Vascular, Inc. · Mar 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · Concentric Medical, Inc. · Mar 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc. · Feb 2001