510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shockwave Medical, Inc.

Santa Clara, CA, US

SHOCKWAVE MEDICAL, INC. appears in FDA device records in Santa Clara, CA. FDA records list 13 510(k) clearances between and , 24 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
13
PMA records
24
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for Shockwave Medical, Inc. between 2016 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shockwave Medical, Inc., by decision year
YearClearances
20162
20182
20191
20211
20222
20243
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPNSubstantially Equivalent
K243757Shockwave CS Guide CatheterDQYSubstantially Equivalent
K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterPPNSubstantially Equivalent
K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterPPNSubstantially Equivalent
K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPNSubstantially Equivalent
K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterPPNSubstantially Equivalent
K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPNSubstantially Equivalent
K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL CatheterPPNSubstantially Equivalent
K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)PPNSubstantially Equivalent
K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector CablePPNSubstantially Equivalent
K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemPPNSubstantially Equivalent
K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector CablePPNSubstantially Equivalent
K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CablePPNSubstantially Equivalent

Registered establishments

FDA registered establishments for Shockwave Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30150538583015053858SHOCKWAVE MEDICAL, INC.5403 Betsy Ross Drive, Santa Clara, CA 95054 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3247-2018The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain