Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PREASSEMBLED SURGICAL WASH SET

K-Number: K103202 · 2010-11-23

ApplicantSorin Group Italia S.R.L.
Decision Date2010-11-23
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREASSEMBLED SURGICAL WASH SET is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K103202. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREASSEMBLED SURGICAL WASH SET?

PREASSEMBLED SURGICAL WASH SET is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K103202.

When did PREASSEMBLED SURGICAL WASH SET receive FDA 510(k) clearance?

PREASSEMBLED SURGICAL WASH SET received FDA 510(k) clearance on 2010-11-23, under 510(k) number K103202.

Who is the listed applicant for PREASSEMBLED SURGICAL WASH SET?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREASSEMBLED SURGICAL WASH SET?

The FDA product code for PREASSEMBLED SURGICAL WASH SET is CAC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sorin Group Italia S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253671Dual Stage Venous CannulaeK251783Inspire HCR and HCR DUAL cardiotomy reservoirsK253616ProtekDilate Vascular Access KitK250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

View all 58 devices →

Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑