10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL

Catheter, Hemodialysis, Implanted

MEDCOMP

The following data is part of a premarket notification filed by Medcomp with the FDA for 10f X 18cm Pediatric Ash Split Cath Xl, Model Aspc18p-xl; 10f X 24cm Pediatric Ash Split-cath Xl, Model Aspc24p-xl.

Pre-market Notification Details

• Device ID: K020936
• 510k Number: K020936
• Device Name: 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
• Classification: Catheter, Hemodialysis, Implanted
• Applicant: MEDCOMP 1499 DELP DR. Harleysville, PA 19438
• Contact: Florence A Caikoski
• Correspondent: Florence A Caikoski; MEDCOMP 1499 DELP DR. Harleysville, PA 19438
• Product Code: MSD
• CFR Regulation Number: 876.5540 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-03-22
• Decision Date: 2002-10-11
• Summary: summary