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

Percutaneous Catheter, Ultrasound

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

PPN is the FDA product code for Percutaneous Catheter, Ultrasound, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PPN
Device name
Percutaneous Catheter, Ultrasound
FDA definition
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
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
14
Ingested recalls
1

Clearances, product code PPN

By decision year
14 clearances under product code PPN with a decision year between 2016 and 2026, 2024 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PPN by decision year
YearClearances
20162
20182
20191
20211
20222
20243
20251
20262

Applicants with the most clearances

Product code PPN
Applicants holding the most 510(k) clearances under product code PPN
ApplicantClearances
Shockwave Medical, Inc.12
Bolt Medical, Inc.1
Bolt Medical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code