STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED

Port & Catheter, Implanted, Subcutaneous, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato Port Introducer Kt(9 Fr) Lps 5513/modified.

Pre-market Notification Details

• Device ID: K905845
• 510k Number: K905845
• Device Name: STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED
• Classification: Port & Catheter, Implanted, Subcutaneous, 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: LJT
• CFR Regulation Number: 880.5965 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-12-27
• Decision Date: 1991-04-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H787LPS55130	K905845	000