.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI

Wire, Guide, Catheter

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi.

Pre-market Notification Details

• Device ID: K993257
• 510k Number: K993257
• Device Name: .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
• Classification: Wire, Guide, Catheter
• Applicant: MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Contact: Tom Daughters
• Correspondent: Tom Daughters; MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-09-29
• Decision Date: 1999-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847536004689	K993257	000
00847536004559	K993257	000
00847536004511	K993257	000
00836462003118	K993257	000
00836462003064	K993257	000
00836462003057	K993257	000