Cleared Special

K001966 - REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND

K001966 is an FDA 510(k) clearance for REBAR MICRO CATHETER: REBAR-18 [2.3F], manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 22-day FDA review.

K001966 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
22d
Days
Class 2
Risk

K001966 is an FDA 510(k) clearance for the REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER .... Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on July 20, 2000 after a review of 22 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.

FDA 510(k) Submission Details - K001966

510(k) Number K001966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2000
Decision Date July 20, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 174
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K001966.
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · Cordis Neurovascular, Inc. · Jan 2001
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · Micro Therapeutics, Inc. · Sep 2000
EXCELSIOR 1018 MICROCATHETER
K994155 · Boston Scientific, Target · Aug 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · Micro Therapeutics, Inc. · Jan 2000
PROWLER PLUS INFUSION CATHETER
K993266 · Cordis Neurovascular, Inc. · Oct 1999
K001966 · REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
Download PDF FDA Summary Micro Therapeutics, I…