Cleared Traditional

K112335 - BANTAM CATHETER (280MM BALLOON LENGTHS)

K112335 is an FDA 510(k) clearance for BANTAM CATHETER (280MM BALLOON LENGTHS), manufactured by ClearStream Technologies , Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K112335 · ClearStream Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
61d
Days
Class 2
Risk

K112335 is an FDA 510(k) clearance for the BANTAM CATHETER (280MM BALLOON LENGTHS). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by ClearStream Technologies , Ltd. (Wexford, IE). The FDA issued a Cleared decision on October 12, 2011 after a review of 61 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.

FDA 510(k) Submission Details - K112335

510(k) Number K112335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2011
Decision Date October 12, 2011
Days to Decision 61 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
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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

Dekra Certification B.V
J.A. VAN VUGT

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.

Regulatory Peers - DQY Catheter, Percutaneous

All 878
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K112335 · BANTAM CATHETER (280MM BALLOON LENGTHS)
Download PDF FDA Summary ClearStream Technolog…