Cleared Traditional

K003570 - BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

K003570 is an FDA 510(k) clearance for BACCHUS THROMBECTOMY CATHETER (BTC), manufactured by Bacchus Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K003570 · Bacchus Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
198d
Days
Class 2
Risk

K003570 is an FDA 510(k) clearance for the BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755. 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 June 6, 2001 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K003570

510(k) Number K003570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date June 06, 2001
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K003570.
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · Rex Medical · May 2003
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
K022640 · Bacchus Vascular, Inc. · Dec 2002
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · Xtrak Medical, Inc. · Mar 2002
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
K993816 · Baxter Edwards · May 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · Possis Medical, Inc. · Apr 2000
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648 · Boston Scientific Corporation Northwest Technology · Nov 1999
K003570 · BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
Download PDF FDA Summary Bacchus Vascular, Inc.