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)

SAFE-1 VENOUS RESERVOIR

K-Number: K893705 · 1989-12-22

ApplicantPolystan C/O Vitalcor, Inc.
Decision Date1989-12-22
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE-1 VENOUS RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Polystan C/O Vitalcor, Inc.. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K893705. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-1 VENOUS RESERVOIR?

SAFE-1 VENOUS RESERVOIR is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Polystan C/O Vitalcor, Inc.. The 510(k) number is K893705.

When did SAFE-1 VENOUS RESERVOIR receive FDA 510(k) clearance?

SAFE-1 VENOUS RESERVOIR received FDA 510(k) clearance on 1989-12-22, under 510(k) number K893705.

Who is the listed applicant for SAFE-1 VENOUS RESERVOIR?

The FDA 510(k) record lists Polystan C/O Vitalcor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-1 VENOUS RESERVOIR?

The FDA product code for SAFE-1 VENOUS RESERVOIR is DTN.

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 Polystan C/O Vitalcor, Inc. 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.

K894657POLYSTAN HEART-LUNG MACHINE SYSTEMK893940POLYSTAN HEATER-COOLER UNITK893704SAFE-1K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSK874853POLYSTAN TWO STAGE CATHETERSK872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

View all 8 devices →

Related Devices (Code: DTN)

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.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

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.

↑