The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Surshield Safety I.v. Catheter (18g X 51mm & 20g X 51mm Sizes).
Device ID | K090973 |
510k Number | K090973 |
Device Name: | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Lynne Witkowski |
Correspondent | Lynne Witkowski TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-05-01 |
Summary: | summary |