510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001966Substantially Equivalent

Rebar Micro Catheter: Rebar-18 [2.3F], 110 Cm, 130 Cm, 153 Cm, Single Marker Band and 153 Cm, Dual Marker Band

Medtronic, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001966 is the FDA 510(k) clearance record for REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND, a class II device, cleared for Micro Therapeutics, Inc. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K001966.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Micro Therapeutics, Inc. 2 Goodyear, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20262
October 20260
November 20260