EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135

Catheter, Intravascular, Diagnostic

BIOSPHERE MEDICAL, INC.

The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Embocath Plus Infusion Microcatheter, Model Ecp-100 And Ecp-135.

Pre-market Notification Details

• Device ID: K062126
• 510k Number: K062126
• Device Name: EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
• Classification: Catheter, Intravascular, Diagnostic
• Applicant: BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370
• Contact: Irina Kulinets
• Correspondent: Irina Kulinets; BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370
• Product Code: DQO
• CFR Regulation Number: 870.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-26
• Decision Date: 2006-08-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884450089200	K062126	000
00884450089194	K062126	000