Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010334444

FEI Number

3010334444

Entity Name

ABLATIVE SOLUTIONS, INC.

City/State/Country

Wakefield, MA, US

Establishment Address

301 Edgewater Place, Suite 100, Wakefield, MA 01880, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Ablative Solutions, Inc. (Owner Number: 10044459)

Owner / Operator Contact Address

301 Edgewater Place, Suite 100, Wakefield, MA 01880, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Peregrine System(TM) Infusion Catheter Peregrine System Infusion Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-02-01
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2013-06-13

Official Correspondent

Kristine Canavan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ablative Solutions, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010334444. Last updated year: 2026. Please use registration number 3010334444 when referencing this establishment in official correspondence.