Cleared Special

K061119 - ENPATH MEDICAL STEERABLE SHEATH

K061119 is an FDA 510(k) clearance for ENPATH MEDICAL STEERABLE SHEATH, manufactured by Enpath Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 27-day FDA review.

K061119 · Enpath Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
27d
Days
Class 2
Risk

K061119 is an FDA 510(k) clearance for the ENPATH MEDICAL STEERABLE SHEATH. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Enpath Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 18, 2006 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Enpath Medical, Inc. devices

FDA 510(k) Submission Details - K061119

510(k) Number K061119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date May 18, 2006
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 671
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