# Cook Pacemaker Corp.

- Location (FDA's records): Leechburg, PA
- FDA decisions: 35 (1981–1997): 34 510(k) clearances and 1 original PMA approval
- Product codes: DXY (25), DTB (7), DQX (1), DXE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Med Institute, Inc.: 1 (https://510kreport.com/company/med-institute)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)

## Its most-cited devices
- K970690: Locking Stylet 2 (1997), cited by 3
- K961992: Needle's Eye Snare (1996), cited by 1

## Recent decisions
- K970690: Locking Stylet 2 (May 20, 1997)
- K961992: Needle's Eye Snare (Dec 27, 1996)
- K953417: Miniflex Model 340, 341, and 342 Pulse Generators (Sep 29, 1995)
- K915188: Model P in-Line Bipolar Endocardial Tined Lead (Sep 11, 1992)
- K905403: Model 340 Series Unipolar & Model 5000B Programmer (Oct 16, 1991)
- P870054: Kelvin Model 500 Unipolar Cardiac Pulse Generator (Apr 29, 1988)
- K863582: Model 725TH Handheld Transceiver (Programmer) (Oct 8, 1986)
- K861559: Series (T) Programmable Cardiac Pulse Generators (May 9, 1986)

Source page: https://510kreport.com/company/cook-pacemaker