510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161384Substantially Equivalent

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

Shockwave Medical, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161384 is the FDA 510(k) clearance record for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable, a class II device, cleared for Shockwave Medical, Inc. on under FDA product code PPN (Percutaneous Catheter, Ultrasound). FDA's definition for product code PPN reads: "Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature". FDA records list 13 510(k) clearances for Shockwave Medical, Inc., from to . As of , FDA records show no recalls naming K161384.

Clearance record

Decision date
Received
(118 days to decision)
Product code
PPN Percutaneous Catheter, Ultrasound
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Shockwave Medical, Inc. 48501 Warm Springs Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PPN

Trailing 12 months
2 clearances under product code PPN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PPN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260