Cleared Special

K050630 - PIVOT STEERABLE MICROCATHETER

K050630 is an FDA 510(k) clearance for PIVOT STEERABLE MICROCATHETER, manufactured by Boston Scientific - Precision Vascular. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 11-day FDA review.

K050630 · Boston Scientific - Precision Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
11d
Days
Class 2
Risk

K050630 is an FDA 510(k) clearance for the PIVOT STEERABLE MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific - Precision Vascular (West Valley City, US). The FDA issued a Cleared decision on March 22, 2005 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Boston Scientific - Precision Vascular devices

FDA 510(k) Submission Details - K050630

510(k) Number K050630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date March 22, 2005
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 140
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K050630.
ECHELON MICRO CATHETER
K051990 · Micro Therapeutics, Inc. · Jan 2006
MIRA-FLEX 18 MICROCATHETER
K052841 · Cook, Inc. · Dec 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · Cordis Neurovascular, Inc. · Apr 2005
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
K042187 · Micro Therapeutics, Inc. · Sep 2004
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · Micro Therapeutics, Inc. · Feb 2004