Cleared Traditional

K112308 - CROSSER RECANALIZATION SYSTEM

K112308 is an FDA 510(k) clearance for CROSSER RECANALIZATION SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K112308 · C.R. Bard, Inc. · Cardiovascular device
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Aug 2011
Decision
6d
Days
Class 2
Risk

K112308 is an FDA 510(k) clearance for the CROSSER RECANALIZATION SYSTEM. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2011 after a review of 6 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K112308

510(k) Number K112308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2011
Decision Date August 17, 2011
Days to Decision 6 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 125d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 45
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