Cleared Traditional

K083596 - REEKROSS FAMILY OR OTW PTA CATHETERS

K083596 is an FDA 510(k) clearance for REEKROSS FAMILY OR OTW PTA CATHETERS, 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 87-day FDA review.

K083596 · ClearStream Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
87d
Days
Class 2
Risk

K083596 is an FDA 510(k) clearance for the REEKROSS FAMILY OR OTW PTA CATHETERS. 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 March 2, 2009 after a review of 87 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 - K083596

510(k) Number K083596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date March 02, 2009
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 SCHAKENRAAD

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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K083596 · REEKROSS FAMILY OR OTW PTA CATHETERS
Download PDF FDA Summary ClearStream Technolog…