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)

CARDIOVASCULAR SAW BLADES

K-Number: K830189 · 1983-03-24

ApplicantTemp Medical Products, Inc.
Decision Date1983-03-24
Product CodeDWH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR SAW BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Temp Medical Products, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830189. The device is classified under product code DWH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR SAW BLADES?

CARDIOVASCULAR SAW BLADES is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Temp Medical Products, Inc.. The 510(k) number is K830189.

When did CARDIOVASCULAR SAW BLADES receive FDA 510(k) clearance?

CARDIOVASCULAR SAW BLADES received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830189.

Who is the listed applicant for CARDIOVASCULAR SAW BLADES?

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

What is the FDA product code for CARDIOVASCULAR SAW BLADES?

The FDA product code for CARDIOVASCULAR SAW BLADES is DWH.

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 Temp Medical Products, 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.

K801914TEMP STERNUM SAW

Related Devices (Code: DWH)

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.

K904352CODMAN COLLINS RADIOPARENT STERNAL BLADESCodman & Shurtleff, Inc.K862474HALL STERNUM SAWHall Surgical, Division of Zimmer, Inc.K850483MICRO-AIRE STERNUM SAW REPLACEMENT BLADESMicro-Aire Surgical Instruments, Inc.

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.

↑