PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT

Catheter, Hemodialysis, Non-implanted

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Pediatric Two-lumen Hemodialysis Catherization Kit.

Pre-market Notification Details

• Device ID: K984022
• 510k Number: K984022
• Device Name: PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
• Classification: Catheter, Hemodialysis, Non-implanted
• 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: MPB
• CFR Regulation Number: 876.5540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-12
• Decision Date: 1999-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801902005564	K984022	000
10801902005561	K984022	000
20801902001072	K984022	000
20801902190042	K984022	000