SEISMIQ Intravascular Lithotripsy System
Summary
Bolt Medical, Inc. received 510(k) clearance for SEISMIQ Intravascular Lithotripsy System, a PPN device. Cleared on 2026-08-24.
Details
Source
510(k) Clearance
External ID
K260246
Action Date
2026-08-24
Status
Traditional
Category
device
Product Code
PPN
Product Description
SEISMIQ Intravascular Lithotripsy System. Product code: PPN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 518 device clearances issued this month. Bolt Medical, Inc. has received 2 total clearances in our database.
Bolt Medical, Inc. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Bolt Medical, Inc. have FDA actions?
Bolt Medical, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260246" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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