# Scimed Life Systems, Inc.

- Location (FDA's records): Maple Grove, MN
- FDA decisions: 111 (1977–1998): 109 510(k) clearances and 2 original PMA approvals
- Product codes: DQX (30), DQY (17), DQO (16), LIT (13), DTZ (6), KRA (6), DTP (4), DTR (3), LOX (3), DTN (3), DTL (3), MAV (2)
- Predicates its devices cite: 67 (62 its own); citations of its devices by later devices: 115 (62 its own)
- Recalls linked to its devices: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- North American Instrument Corp.: 1 (https://510kreport.com/company/north-american-instrument)
- Medex, Inc.: 1 (https://510kreport.com/company/medex)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Cardio Metrics, Inc.: 1 (https://510kreport.com/company/cardio-metrics)
- Localmed, Inc.: 1 (https://510kreport.com/company/localmed)

## Firms that cite its devices most
- Boston Scientific Corp: 15 (https://510kreport.com/company/boston-scientific)
- Brosmed Medical Co., Ltd.: 3 (https://510kreport.com/company/brosmed-medical)
- Trireme Medical, Inc.: 2 (https://510kreport.com/company/trireme-medical)
- Orbusneich Medical, Inc.: 2 (https://510kreport.com/company/orbusneich-medical)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Biocardia, Inc.: 2 (https://510kreport.com/company/biocardia)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Velocimed, Inc.: 1 (https://510kreport.com/company/velocimed)

## Its most-cited devices
- P860019: Scimed Ptca Dilatation Catheter (1986), cited by 21
- K945129: Scimed Chioce Plus Ptca Guide Wire (1995), cited by 6
- K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter (1993), cited by 6
- K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire (1996), cited by 6
- K950113: Scimed (R) Chice (TM) Exchange Ptca Guide Wire (1995), cited by 6
- K943192: Scimed Choice (TM) Ptca Guide Wire (1994), cited by 5

## Recent decisions
- K974241: Scimed Informer Pressure Wire System (Nov 12, 1998)
- K981788: Scimed 6 French Wiseguide Guide Catheter (Aug 18, 1998)
- K980360: Scimed Quest Floppy and Moderate Support Guide Wires (Apr 29, 1998)
- K974559: Scimed 6 French Impulse Angiographic Catheters (Feb 23, 1998)
- K974684: Scimed 7 French Wiseguide Guide Catheter (Feb 19, 1998)
- K973945: Luge Guide Wire (Jan 12, 1998)
- K970823: Scimed 8 French Wiseguide Guide Catheter (Jun 3, 1997)
- K964551: Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid (May 21, 1997)

Source page: https://510kreport.com/company/scimed-life-systems