Cleared Traditional

K926000 - 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER

K926000 is an FDA 510(k) clearance for 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLO..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K926000 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
276d
Days
Class 2
Risk

K926000 is an FDA 510(k) clearance for the 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on August 30, 1993 after a review of 276 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 - K926000

510(k) Number K926000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1992
Decision Date August 30, 1993
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSP Device Classification - Class 2, Special Controls

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 145
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K926000.
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
K940178 · Datascope Corp. · Aug 1994
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · Kontron Instruments, Inc. · Dec 1993
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248 · Kontron Instruments, Inc. · Sep 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000 · Datascope Corp. · Aug 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · Datascope Corp. · Aug 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · Datascope Corp. · Aug 1993