510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MCWClass II

Catheter, Peripheral, Atherectomy

21 CFR 870.4875 / Cardiovascular
FDA source (opens on fda.gov)

MCW is the FDA product code for Catheter, Peripheral, Atherectomy, a class II device type, regulated under 21 CFR 870.4875. As of , FDA records hold 146 510(k) clearances under this code, the most recent dated , and 34 recalls.

Classification record

Product code
MCW
Device name
Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
146
Ingested recalls
34

Clearances, product code MCW

By decision year
146 clearances under product code MCW with a decision year between 1990 and 2026, 2009 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code MCW by decision year
YearClearances
19902
19911
19923
19932
19941
19952
19964
19975
19982
19993
20002
20011
20022
20034
20043
20052
20065
20075
20086
20098
20106
20116
20125
20135
20147
20156
20165
20177
20188
20193
20202
20216
20226
20234
20243
20253
20261

Applicants with the most clearances

Product code MCW
Applicants holding the most 510(k) clearances under product code MCW
ApplicantClearances
Cardiovascular Systems Incorporated21
Pathway Medical Technologies, Inc.16
Medtronic, Inc.14
Avinger, Inc.10
Spectranetics Corp.10
Eximo Medical Ltd8
Rex Medical LP8
Volcano Atheromed, Inc.6
Boston Scientific Corporation5
Cardio Flow, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order