FDA Registration Active 🇺🇸 United States

6F GREEN INPUT 23 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER

Reg #: 2011171 · FEI: 2011171 · Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics US LLC
Registration Number
2011171
FEI Number
2011171
Status
Active
Expiry Year
2025
Initial Importer
No
Address
4900 Gifford Ave
City
Los Angeles
State
CA
ZIP
90058
Country
US

Regulatory Submissions

510(k) Number
K980973

Owner / Operator

Firm Name
Sotera Health LLC
Operator Number
10029425
Address
2015 Spring Road, Suite 650
City
Oak Brook
State
IL
Postal Code
60523
Country
US
Correspondent
Karen Whaley-Krumins

Products

Device Name Product Code
Catheter, Intravascular, Diagnostic DQO

Proprietary Names

6F GREEN INPUT 23 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER 6F PF CHOICE PK ST XT KIT MEDTRONIC ANGIOGRAPHIC CATHETER 6F PF ST ARI MEDTRONIC ANGIOGRAPHIC CATHETER 6F PF ST JR3.5 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 6F 23CM INPUT INTRO. KIT MEDTRONIC ANGIOGRAPHIC CATHETER 6F PF ST JR6 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 5F SS MP B-1 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 8F BLUE INPUT 11 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER 7F 23CM OBTURATOR ASSEMBLY MEDTRONIC ANGIOGRAPHIC CATHETER 6F 11 CM ENHANCED INPUT TS CATHETER MEDTRONIC ANGIOGRAPHIC CATHETER 6F 23CM ENHANCED INPUT TS MEDTRONIC ANGIOGRAPHIC CATHETER 7F EI TS 23CM OBTURATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER INPUT 2 26CM STER SLEV W/OCCL MEDTRONIC ANGIOGRAPHIC CATHETER 6F 23CM ENHANCED INSERTION MEDTRONIC ANGIOGRAPHIC CATHETER 7F 23CM ENHANCED INSERTION MEDTRONIC ANGIOGRAPHIC CATHETER 4F SS CHAMP 0.5 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 7F PF XT 110 PIGTAIL MEDTRONIC ANGIOGRAPHIC CATHETER 6F SS SONES C 80CM MEDTRONIC ANGIOGRAPHIC CATHETER 5F GREY INPUT 11 ASSY MEDTRONIC ANGIOGRAPHIC CATHETER 8F ADULT TRANSEPTAL HEMAQUET SHEATH ASSEMBLY TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET 6F SS AR 1 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 6F SS NTR 100CM MEDTRONIC ANGIOGRAPHIC CATHETER 5F 11CM INPUT INTROD MEDTRONIC ANGIOGRAPHIC CATHETER

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)