Cleared Special

K033997 - SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110

K033997 is an FDA 510(k) clearance for SOLERA PLUS 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 42-day FDA review.

K033997 · Bacchus Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
42d
Days
Class 2
Risk

K033997 is an FDA 510(k) clearance for the SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, .... 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 February 4, 2004 after a review of 42 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K033997

510(k) Number K033997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date February 04, 2004
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 K033997.
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K024243 · Fox Hollow Technologies · Jun 2003
K033997 · SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
Download PDF FDA Summary Bacchus Vascular, Inc.