Cleared Traditional

K083833 - ENABLER-P CATHETER, 1000 PART NUMBER:1160

K083833 is an FDA 510(k) clearance for ENABLER-P CATHETER, manufactured by Endocross, Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K083833 · Endocross, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
150d
Days
Class 2
Risk

K083833 is an FDA 510(k) clearance for the ENABLER-P CATHETER, 1000 PART NUMBER:1160. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Endocross, Ltd. (Washington, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Endocross, Ltd. devices

FDA 510(k) Submission Details - K083833

510(k) Number K083833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2008
Decision Date May 22, 2009
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
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 669
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K083833.
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