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)

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE

K-Number: K880740 · 1988-03-22

ApplicantSpectramed, Inc.
Decision Date1988-03-22
Product CodeDQF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1988-03-22 under 510(k) number K880740. The device is classified under product code DQF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Spectramed, Inc.. The 510(k) number is K880740.

When did MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE receive FDA 510(k) clearance?

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE received FDA 510(k) clearance on 1988-03-22, under 510(k) number K880740.

Who is the listed applicant for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

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

What is the FDA product code for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

The FDA product code for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE is DQF.

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 Spectramed, 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

View all 13 devices →

Related Devices (Code: DQF)

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.

K920177VERSA-VIALBioteque America, Inc.K882723ALCON FLUID INJECTORAlcon Laboratories

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.

↑