# DWS: Instruments, Surgical, Cardiovascular

- Device class: 1; regulation: 21 CFR 870.4500; FDA's rule: 510(k) exempt
- FDA decisions: 71
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1984: 3
- 1985: 8
- 1986: 2
- 1988: 9
- 1989: 6
- 1990: 2
- 1994: 1
- 1996: 5
- 1997: 1
- 2002: 1

## Most-cited predicates
- K851140: Teleflex Medical Introducer Needle (1985), cited by 4
- K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006) (1997), cited by 4
- K851834: Manan Gwi Guide Wire Introducer (1985), cited by 3
- K800122: Hancock Aortic Punch (1980), cited by 1
- K851833: Manan Seldinger Needle (1985), cited by 1
- K760624: Small Vessel Cannula (1976), cited by 1
- K851832: Naman Potts Cournand Needle (1985), cited by 1
- K760351: Catheter, Argyle Thoracic (1976), cited by 1
- K890707: Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial (1989), cited by 1

Source page: https://510kreport.com/product-code/DWS
Data by year (CSV): https://510kreport.com/product-code/DWS.csv