TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION

Port & Catheter, Implanted, Subcutaneous, Intravascular

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Two-lumen Picc With Blue Flextip Catheter And Integral Needle Protection.

Pre-market Notification Details

• Device ID: K003006
• 510k Number: K003006
• Device Name: TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Contact: Thomas D Nickel
• Correspondent: Thomas D Nickel; ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605
• Product Code: LJT
• CFR Regulation Number: 880.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-26
• Decision Date: 2000-10-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30801902095337	K003006	000
20801902113805	K003006	000
20801902113799	K003006	000
20801902112990	K003006	000
40801902123228	K003006	000
40801902123235	K003006	000
20801902113386	K003006	000
20801902113379	K003006	000
20801902095330	K003006	000
20801902198802	K003006	000
20801902012931	K003006	000
40801902113373	K003006	000
30801902093357	K003006	000
30801902092824	K003006	000
30801902092817	K003006	000
30801902092794	K003006	000
30801902083389	K003006	000
30801902081477	K003006	000
30801902067457	K003006	000
30801902012938	K003006	000
60801902113384	K003006	000
20801902198796	K003006	000