Cleared Special

K022640 - SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM

K022640 is an FDA 510(k) clearance for SOLERA MAGNUM THROMBECTOMY CATHETER, manufactured by Bacchus Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 116-day FDA review.

K022640 · Bacchus Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
116d
Days
Class 2
Risk

K022640 is an FDA 510(k) clearance for the SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MA.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Bacchus Vascular, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 - K022640

510(k) Number K022640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2002
Decision Date December 02, 2002
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K022640.
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
K030504 · Idev Technologies, Inc. · Sep 2003
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · Fox Hollow Technologies · Jun 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · Rex Medical · May 2003
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · Xtrak Medical, Inc. · Mar 2002
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · Bacchus Vascular, Inc. · Jun 2001
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
K993816 · Baxter Edwards · May 2000
K022640 · SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Download PDF FDA Summary Bacchus Vascular, Inc.