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

Catheter For Crossing Total Occlusions

21 CFR 870.1250 / Cardiovascular
FDA source (opens on fda.gov)

PDU is the FDA product code for Catheter For Crossing Total Occlusions, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement". As of , FDA records hold 58 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
PDU
Device name
Catheter For Crossing Total Occlusions
FDA definition
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Regulation
21 CFR 870.1250
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
No
Ingested clearances
58
Ingested recalls
7

Clearances, product code PDU

By decision year
58 clearances under product code PDU with a decision year between 2003 and 2026, 2012 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code PDU by decision year
YearClearances
20033
20042
20054
20062
20074
20082
20092
20103
20113
20126
20131
20143
20152
20162
20171
20191
20202
20213
20224
20233
20241
20253
20261

Applicants with the most clearances

Product code PDU
Applicants holding the most 510(k) clearances under product code PDU
ApplicantClearances
Avinger, Inc.10
Spectranetics Corp.7
Boston Scientific Corporation3
Flowcardia, Inc.3
Lumend, Inc.3
Medtronic, Inc.3
Ra Medical Systems,Inc3
Baylis Medical Co., Inc.2
Baylis Medical Technologies Inc.2
C.R. Bard Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order