Cleared Traditional

K042538 - SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX

K042538 is an FDA 510(k) clearance for SAILOR PLUS PERCUTANEOUS TRANSLUMINAL A..., manufactured by Invatec Innovative Technologies. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K042538 · Invatec Innovative Technologies · Cardiovascular device
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Nov 2004
Decision
49d
Days
Class 2
Risk

K042538 is an FDA 510(k) clearance for the SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXX.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Invatec Innovative Technologies (Plymouth, US). The FDA issued a Cleared decision on November 8, 2004 after a review of 49 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 Invatec Innovative Technologies devices

FDA 510(k) Submission Details - K042538

510(k) Number K042538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date November 08, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQY Catheter, Percutaneous

All 688
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