# Pressure Products Medical Device Manufacturing, LLC

- Location (FDA's records): Morton, PA
- FDA decisions: 9 (2017–2026): 9 510(k) clearances
- Product codes: DRC (7), DXF (1), DYB (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oscor, Inc.: 2 (https://510kreport.com/company/oscor)
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Daig Corp.: 1 (https://510kreport.com/company/daig)

## Its most-cited devices
- K170671: SafeSept Transseptal Guidewire (2017), cited by 1
- K172934: Needle Free Transseptal Cannula (2018), cited by 1
- K172950: TSN Transseptal Needle (2018), cited by 1

## Recent decisions
- K253799: SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (Mar 13, 2026)
- K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (May 17, 2024)
- K221707: SafeSept® Transseptal Guidewire (SS-140) (Sep 14, 2022)
- K210328: SafeSept Blunt Needle (Mar 5, 2021)
- K181031: TSI Transseptal Introducer (Oct 26, 2018)
- K172950: TSN Transseptal Needle (Feb 21, 2018)
- K172934: Needle Free Transseptal Cannula (Feb 16, 2018)
- K172893: SafeSept Needle Free Transseptal Guidewire (Dec 21, 2017)

Source page: https://510kreport.com/company/pressure-products-medical-device-manufacturing