FDA Registration Active 🇺🇸 United States

PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Curled, Double Cuff (Ref M7200)

Reg #: 2030624 · FEI: 3000206435 · Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Isomedix Operations, Inc.
Registration Number
2030624
FEI Number
3000206435
Status
Active
Expiry Year
2025
Initial Importer
No
Address
43425 Business Park Dr
City
Temecula
State
CA
ZIP
92590
Country
US

Regulatory Submissions

510(k) Number
K113354

Owner / Operator

Firm Name
STERIS Corporation
Operator Number
1527821
Address
5960 Heisley Rd, --
City
Mentor
State
OH
Postal Code
44060
Country
US

Products

Device Name Product Code
Catheter, Peritoneal, Long-Term Indwelling FJS

Proprietary Names

PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Curled, Double Cuff (Ref M7200) PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Straight, Double Cuff (Ref M7100) PFMMedical6614 (TM) - VETA Peritoneal Catheter Kit with Curled Catheter (Ref M7225) PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter (Ref M7150)

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)