SAPPHIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

ORBUSNEICH MEDICAL, INC.

The following data is part of a premarket notification filed by Orbusneich Medical, Inc. with the FDA for Sapphire.

Pre-market Notification Details

• Device ID: K103657
• 510k Number: K103657
• Device Name: SAPPHIRE
• Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale, FL 33309 -6315
• Contact: John Pazienza
• Correspondent: John Pazienza; ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale, FL 33309 -6315
• Product Code: LOX
• CFR Regulation Number: 870.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-15
• Decision Date: 2011-08-09
• Summary: summary