FDA Registration Active 🇮🇪 Ireland

Telemark Microcatheter

Reg #: 3005994106 · FEI: 3005994106 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Creagh Medical Ltd.
Registration Number
3005994106
FEI Number
3005994106
Status
Active
Expiry Year
2025
Initial Importer
No
Address
IDA Business Park, Ballinasloe
City
Co. Galway
Country
IE

Regulatory Submissions

510(k) Number
K173560

Owner / Operator

Firm Name
Surmodics, Inc
Operator Number
10023361
Address
9924 W 74th street
City
Eden Prairie
State
MN
Postal Code
55344
Country
US

US Agent

Business Name
Surmodics
Contact Name
Carla Erickson
Address
9924 West 74th Street
City
Eden Prairie
State
MN
ZIP
55344
Country
US
Phone
952 5007258

Products

Device Name Product Code
Catheter, Percutaneous DQY

Proprietary Names

Telemark Microcatheter

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device