Pressure Products Medical Device Manufacturing LLC
Morton, PA, US
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC appears in FDA device records in Morton, PA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Pressure Products Medical Device Manufacturing LLC between 2017 and 2026. The busiest year on record is 2018, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | DXF | Substantially Equivalent | |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | DRC | Substantially Equivalent | |
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | DRC | Substantially Equivalent | |
| K210328 | SafeSept Blunt Needle | DRC | Substantially Equivalent | |
| K181031 | TSI Transseptal Introducer | DYB | Substantially Equivalent | |
| K172950 | TSN Transseptal Needle | DRC | Substantially Equivalent | |
| K172934 | Needle Free Transseptal Cannula | DRC | Substantially Equivalent | |
| K172893 | SafeSept Needle Free Transseptal Guidewire | DRC | Substantially Equivalent | |
| K170671 | SafeSept Transseptal Guidewire | DRC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013986346 | 3013986346 | PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC | 1 School Street, Morton, PA 19070 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain