# K981365: Mahurkar 13.5 FR Cuffed Catheter with Curved Extensions

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Nov 25, 1998 after 224 days
- Product code: MSD (Catheter, Hemodialysis, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PermCath Dual Lumen Catheters: named in the summary without a submission number

## Indications for use
The Mahurkar 13.5 Fr Cuffed Silicone catheter is designed for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

Source page: https://510kreport.com/device/K981365
Methodology: https://510kreport.com/methodology