SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

SHIN CHANG MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Shin Chang Medical Co., Ltd. with the FDA for Scm Cath ( Sizes Are Varying Between 16g X 2'' And 24g X 3/4'' ), Model 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,.

Pre-market Notification Details

• Device ID: K071382
• 510k Number: K071382
• Device Name: SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115
• Contact: Jan J Frank
• Correspondent: Jan J Frank; SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-17
• Decision Date: 2007-10-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10612479212654	K071382	000
10612479212623	K071382	000
10612479212593	K071382	000
10612479212562	K071382	000
20853620005221	K071382	000
10853620005187	K071382	000