# K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Nov 10, 1999 after 205 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974236 (1999). 1 ancestor in all.
16 later devices descend from it; 3 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB, Medical Components, Inc. (1999) Summary page 1.

## Most influential descendants
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (2006), 7 descendants of its own
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 descendants of its own
- K023914: Coaxia Flocontrol Catheter (2003), 6 descendants of its own
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), 5 descendants of its own
- K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath (2013), 4 descendants of its own

## Indications for use
The Medcomp Duo-Coat Catheter is indicated for use in attaining short term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site are the subclavian or femoral vein.

Source page: https://510kreport.com/device/K991320
Methodology: https://510kreport.com/methodology