Cleared Traditional

K970296 - ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

K970296 is an FDA 510(k) clearance for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTE..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K970296 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
214d
Days
Class 2
Risk

K970296 is an FDA 510(k) clearance for the ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Boston Scientific Corp (Redmond, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 214 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.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K970296

510(k) Number K970296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date August 29, 1997
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K970296.
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
K973669 · Micro Therapeutics, Inc. · Feb 1998
GELBFISH ENDO-VAC SYSTEM
K970233 · Gary A. Gelbfish · Oct 1997
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
K971984 · Microvena Corp. · Sep 1997
THROMBOLYTIC BRUSH CATHETER
K963925 · Micro Therapeutics, Inc. · Aug 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · Arrow Intl., Inc. · Jul 1997
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
K960970 · Possis Medical, Inc. · Dec 1996