# K974742: Manan Potts-Cournand Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Apr 6, 1998 after 108 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- 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 K851832 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851832: Naman Potts Cournand Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.

## Indications for use
The Manan™ Potts-Cournand Needle is intended for use for carotid angiography, direct arterial pressure monitoring, blood sampling, and percutaneous catheterization.

Source page: https://510kreport.com/device/K974742
Methodology: https://510kreport.com/methodology