PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC

FDA Device Registration & Listing · Morton, PA, US · Registration 3013986346

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013986346
FEI Number
3013986346
Entity Name
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
City/State/Country
Morton, PA, US
Establishment Address
1 School Street, Morton, PA 19070, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Pressure Products Medical Device Manufacturing LLC (Owner Number: 10052778)
Owner / Operator Contact Address
1 School Street, Morton, PA 19070, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181031
PMA Number
N/A

All Registered Proprietary Names

SafeSept Transseptal Guidewire SafeSept Needle Free Transseptal Guidewire TSN Transseptal Needle TSI Transseptal Introducer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRC Trocar Cardiovascular Class 2 870.1390 2022-09-20
DRC Trocar Cardiovascular Class 2 870.1390 2017-12-28
DRC Trocar Cardiovascular Class 2 870.1390 2018-02-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-10-27

Official Correspondent

Andrew Armour

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pressure Products Medical Device Manufacturing LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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2030624 Isomedix Operations, Inc. Temecula, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013986346. Last updated year: 2026. Please use registration number 3013986346 when referencing this establishment in official correspondence.
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