Cleared Traditional

K083139 - VIPERSPHERE PTA BALLOON CATHETER

K083139 is an FDA 510(k) clearance for VIPERSPHERE PTA BALLOON CATHETER, manufactured by Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K083139 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
33d
Days
Class 2
Risk

K083139 is an FDA 510(k) clearance for the VIPERSPHERE PTA BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 33 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 Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K083139

510(k) Number K083139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2008
Decision Date November 25, 2008
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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

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.

Regulatory Peers - DQY Catheter, Percutaneous

All 780
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