AGILE DEVICES, INC.

FDA Device Registration & Listing · Newton Centre, MA, US · Registration 3023167283

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023167283
FEI Number
3023167283
Entity Name
AGILE DEVICES, INC.
City/State/Country
Newton Centre, MA, US
Establishment Address
1087 Beacon Street, Suite 302, Newton Centre, MA 02459, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Agile Devices, Inc. (Owner Number: 10085522)
Owner / Operator Contact Address
1087 Beacon Street, Suite 302, Newton Centre, MA 02459, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211110
PMA Number
N/A

All Registered Proprietary Names

Angler Steerable, Deflectable Microcatheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-06-28

Official Correspondent

Benjamin Merewitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Agile Devices, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023167283. Last updated year: 2026. Please use registration number 3023167283 when referencing this establishment in official correspondence.
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