CRICKET

Wire, Guide, Catheter

MICROVENA CORP.

The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Cricket.

Pre-market Notification Details

• Device ID: K955304
• 510k Number: K955304
• Device Name: CRICKET
• Classification: Wire, Guide, Catheter
• Applicant: MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426
• Contact: Jodi Locher
• Correspondent: Jodi Locher; MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-20
• Decision Date: 1996-05-16
• Summary: summary