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)

MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2

K-Number: K781553 · 1978-10-26

ApplicantSorensen Research
Decision Date1978-10-26
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1978-10-26 under 510(k) number K781553. 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 MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2?

MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 is a medical device that received FDA 510(k) clearance on 1978-10-26. The listed applicant is Sorensen Research. The 510(k) number is K781553.

When did MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 receive FDA 510(k) clearance?

MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 received FDA 510(k) clearance on 1978-10-26, under 510(k) number K781553.

Who is the listed applicant for MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2?

The FDA 510(k) record lists Sorensen Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2?

The FDA product code for MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 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 Sorensen Research 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.

K833674ACCURATE MEASUREMENT DEVICE KG-AMDK833673ACCURATE MEASUREMENT DEVICE EZ-AMDK833095TRANSDUCER DOME SD105K833094TRANSDUCER DOME SD104K833096TRANSDUCER DOME DS106K832957FLOW-DIRECTED HEPARIN COATED THERMODIL

View all 69 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.

↑