Data / Medical devices / United States / Ablative Solutions, Inc.
Ablative Solutions, Inc.: FDA-registered device maker in Wakefield, MA, United States, 1 510(k) clearance
Ablative Solutions, Inc. is registered with the FDA (registration 3010334444) in Wakefield, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 5, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010334444
- Address
- 301 Edgewater Place Suite 100, Wakefield, MA, United States, 01880
- Owner or operator
- Ablative Solutions, Inc. (10044459)
- Roles
- Complaint file establishment, Manufacturer for export, Specification developer
- First device listed
- June 13, 2013
- Registered through
- 2027
- Brand names listed
- Peregrine System Infusion Catheter, Peregrine System(TM) Infusion Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 5, 2023 | K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | KRA | Substantially Equivalent | Ablative Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 5, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.