Cleared Traditional

K970296 - ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTE...

K970296 is the FDA 510(k) clearance for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTE... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 52
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K970296.
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · Boston Scientific Corp · Feb 1999
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
K973669 · Micro Therapeutics, Inc. · Feb 1998
THROMBOLYTIC BRUSH CATHETER
K963925 · Micro Therapeutics, Inc. · Aug 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · Arrow Intl., Inc. · Jul 1997
TRAC-WRIGHT TRAC 10 CATHETER
K915238 · Dow Corning Wright · Feb 1992