SOUTH53

FDA Device Registration & Listing · San Juan Capistrano, CA, US · Registration 3037047821

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
3037047821
FEI Number
3037047821
Entity Name
SOUTH53
City/State/Country
San Juan Capistrano, CA, US
Establishment Address
27131 Calle Arroyo Ste 1722, San Juan Capistrano, CA 92675, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
South53 (Owner Number: 10094165)
Owner / Operator Contact Address
27131 Calle Arroyo, Ste 1722, San Juan Capistrano, CA 92675, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252441
PMA Number
N/A

All Registered Proprietary Names

Primero Safe Access System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-11-19

Official Correspondent

Rodney Brenneman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

South53
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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2020394 BARD PERIPHERAL VASCULAR, INC. TEMPE, AZ, US
3016904853 SAINT JONES MANAGEMENT LP EOOD Sofia Sofia-Grad, BG
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037047821. Last updated year: 2026. Please use registration number 3037047821 when referencing this establishment in official correspondence.
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