Cleared Traditional

K120533 - BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES

K120533 is an FDA 510(k) clearance for BIGBOSS CATHETERS MANTATAY CATHETER MAN..., manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K120533 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
90d
Days
Class 2
Risk

K120533 is an FDA 510(k) clearance for the BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Bridgepoint Medical (Plymouth, US). The FDA issued a Cleared decision on May 22, 2012 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 - K120533

510(k) Number K120533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2012
Decision Date May 22, 2012
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01246505 Completed Interventional Industry-sponsored

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

105
Patients (actual)
10
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Total Occlusion
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator William A Gray, MD
Sponsor BridgePoint Medical (industry)
Started 2011-07-01 → Primary completion 2011-12-01 → Completed 2012-01-01
Primary outcome
Incidence of Patients with a Major Adverse Events (MAE)
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 57
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K120533.
OCELOT PIXL CATHETER
K123532 · Avinger, Inc. · Dec 2012
OCELOT CATHETER
K123462 · Avinger, Inc. · Dec 2012
OCELOT SYSTEM
K122380 · Avinger, Inc. · Nov 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · Avinger, Inc. · Mar 2012
WILDCAT CATHETER
K113838 · Avinger, Inc. · Mar 2012
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
K120533 · BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
Download PDF FDA Summary Bridgepoint Medical