# Pacesetter, Inc.

- Location (FDA's records): Sylmar, CA
- FDA decisions: 8 (1995–1998): 8 510(k) clearances
- Product codes: DTB (6), CAF (1), DTD (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
- Newport Medical Instruments, Inc.: 1 (https://510kreport.com/company/newport-medical-instruments)
- Aerogen, Ltd.: 1 (https://510kreport.com/company/aerogen)
- Puritan-Bennett Ireland, Ltd.: 1 (https://510kreport.com/company/puritan-bennett-ireland)
- Synovis Surgical Innovations: 1 (https://510kreport.com/company/synovis-surgical-innovations)

## Its most-cited devices
- K960854: Siemens Servo Ultra Nebulizer 345 (1996), cited by 3
- K972814: Locator Model 4036 (1998), cited by 1

## Recent decisions
- K972814: Locator Model 4036 (Feb 23, 1998)
- K960854: Siemens Servo Ultra Nebulizer 345 (Dec 23, 1996)
- K954714: Afp Cardiac Pacing System Model 283 (Modification) (Feb 1, 1996)
- K954551: DF-1 Terminal Cap (Dec 26, 1995)
- K952206: Passive Plus Pacing Leads with Titanium Nitride Coating (Aug 31, 1995)
- K951950: Passive Plus Pacing Leads with Titanium Nitride Coating (Aug 31, 1995)
- K951087: Tendril, Unipolar Endocardial Screw-in Lead (Jun 29, 1995)
- K950140: IS-1/Quadripolar Terminal Cap, Part Number 6011069 (Apr 6, 1995)

Source page: https://510kreport.com/company/pacesetter