Cleared Traditional

K082935 - VISION WIRE CORONARY GUIDEWIRE

K082935 is the FDA 510(k) clearance for VISION WIRE CORONARY GUIDEWIRE by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K082935 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
64d
Days
Class 2
Risk

K082935 is an FDA 510(k) clearance for the VISION WIRE CORONARY GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K082935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date December 04, 2008
Days to Decision 64 days
Submission Type Traditional
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 488
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K082935.
ASAHI SUOH PTCA GUIDE WIRE
K083904 · Asahi Intecc Co., Ltd. · Jan 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
K083145 · Asahi Intecc Co., Ltd. · Jan 2009
FREEWAY AND RAILRUNNER GUIDEWIRES
K082922 · Lake Region Mfg., Inc. · Dec 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · Asahi Intecc Co., Ltd. · Nov 2008
ROLL-X GUIDEWIRE
K082304 · St Jude Medical · Aug 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp · Aug 2008