FDA 510(k) Premarket Notification K232130: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

Submission Details & Decision

Normalized public record details for 510(k) notification K232130.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K232130

Applicant / Sponsor

Surgical Instrument Services and Savings, Inc.

Device Name

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

Product Code

OWQ

Decision Date

2023-12-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2023-07-17

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1061124 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
IRVINE BIOMEDICAL. INC. Registration: 2030404 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
Stryker Sustainability Solutions Phoenix Registration: 2090040 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
NORTHEAST SCIENTIFIC, INC. Registration: 3005467144 View Registration
Abbott Medical Costa Rica Ltda. Registration: 3008452825 View Registration
Stryker Sustainability Solutions Registration: 3009350690 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Nypro Inc (Maple Grove) Registration: 3011024991 View Registration
STERILMED, INC. Registration: 3011276773 View Registration
INNOVATIVE HEALTH, LLC. Registration: 3011610434 View Registration
St. Jude Medical Registration: 3012179728 View Registration
VEIN360 Registration: 3015988948 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
Abbott Medical Mexico, S. de R.L. de C.V. Registration: 3038966633 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.