# Harmac Medical Products, Inc.

- Location (FDA's records): Buffalo, NY
- FDA decisions: 8 (1995–2002): 8 510(k) clearances
- Product codes: FPA (2), LDF (2), DQO (2), DYG (1), DRF (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medcare Medical Group, Inc.: 1 (https://510kreport.com/company/medcare-medical-group)

## Its most-cited devices
- K950895: Harmac Extension Infusion Set (1995), cited by 1

## Recent decisions
- K021916: Harmac Huber Needle Safety Device, H2984001 (Aug 29, 2002)
- K963335: Harmac Balloon Wedge Pressure Catheter (Oct 16, 1997)
- K962829: Harmac Balloon Angiographic Catheter (Oct 16, 1997)
- K962833: Harmac Temporary Pacing Catheter with Balloon (Oct 15, 1997)
- K963073: Harmac Bipolar Temporary Pacing Catheter with Stylet (Aug 14, 1997)
- K963336: Harmac Thermodilution Catheter (Aug 14, 1997)
- K963074: Harmac Quadpolar Mapping Pacing Catheter (Jun 25, 1997)
- K950895: Harmac Extension Infusion Set (Sep 1, 1995)

Source page: https://510kreport.com/company/harmac-medical-products