LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE

Set, Administration, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Lifeport Infusion Set And Infusion Set W/ Y Site.

Pre-market Notification Details

• Device ID: K921674
• 510k Number: K921674
• Device Name: LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
• Classification: Set, Administration, Intravascular
• Applicant: STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915
• Contact: Nancy C Hall
• Correspondent: Nancy C Hall; STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-08
• Decision Date: 1992-09-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H787LPS30255	K921674	000
H787LPS30235	K921674	000
H787LPS30175	K921674	000
H787LPS30095	K921674	000
H787LPS30085	K921674	000
H787LPS30075	K921674	000
H787LPS30065	K921674	000
H787LPS30055	K921674	000
H787LPS30045	K921674	000