BIOWY CORPORATION

FDA Device Registration & Listing · Lake Forest, CA, US · Registration 3013233645

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
3013233645
FEI Number
3013233645
Entity Name
BIOWY CORPORATION
City/State/Country
Lake Forest, CA, US
Establishment Address
27031 Vista Terrace, Lake Forest, CA 92630, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Biowy Corporation (Owner Number: 10057786)
Owner / Operator Contact Address
27031 Vista Terrace, 27002 Vista Terrace, Lake Forest, CA 92630, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Biowy Tym Tube Biowy Corporation BIOWY FREEZING BAG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2024-09-04
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-05-25
LPZ Container, Frozen Donor Tissue Storage Unknown Class U N/A 2018-06-21

Official Correspondent

Zhihua Lu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biowy Corporation
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
K971999 B.Braun Medical, Inc. PERIPHERALLY INSERTED CENTRAL 1997-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013233645. Last updated year: 2026. Please use registration number 3013233645 when referencing this establishment in official correspondence.
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