510(k) clearances

Bolt Intravascular Lithotripsy (IVL) System

Bolt Medical, Inc. · Cardiovascular

K250225Substantially EquivalentTraditionalPPN
Open FDA's page for this record
Third party flag
N
City
Carlsbad
Advisory committee description
Cardiovascular
Address 1
2131 Faraday Ave.
Statement or summary
Summary
Product code
PPN
Zip code
92008
Applicant
Bolt Medical, Inc.
Decision date
2025-03-25
Decision code
SESE
Country code
US
Device name
Bolt Intravascular Lithotripsy (IVL) System
Advisory committee
CV
Contact
Stephanie Onstot
K number
K250225
State
CA
Date received
2025-01-27
Review advisory committee
CV
Postal code
92008
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Percutaneous Catheter, Ultrasound
Medical specialty description
Cardiovascular
Regulation number
870.1250
Device class
2
Registration number
3007738736, 3012102437, 3014222368, 3015053858, 3010086866, 2030624, 2030598, 1000121056, 3041000776, 2124215, 3010273872, 3009018440, 3004363082, 3027545377
FEI number
3007738736, 3012102437, 3014222368, 3015053858, 3010086866, 1000121056, 3041000776, 3000206435, 2124215, 3010273872, 3009018440, 3004363082, 1000518731, 3027545377
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.