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FDA 510(k)

RDI CARDIAC INSULATION PAD

K-Number: K960312 · 1996-04-19

ApplicantR D Intl.
Decision Date1996-04-19
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RDI CARDIAC INSULATION PAD is the device name listed in this FDA 510(k) record. The listed applicant is R D Intl.. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K960312. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDI CARDIAC INSULATION PAD?

RDI CARDIAC INSULATION PAD is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is R D Intl.. The 510(k) number is K960312.

When did RDI CARDIAC INSULATION PAD receive FDA 510(k) clearance?

RDI CARDIAC INSULATION PAD received FDA 510(k) clearance on 1996-04-19, under 510(k) number K960312.

Who is the listed applicant for RDI CARDIAC INSULATION PAD?

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

What is the FDA product code for RDI CARDIAC INSULATION PAD?

The FDA product code for RDI CARDIAC INSULATION PAD is DWP.

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 R D Intl. 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.

K960937SUCTION SAFETY DEVICE

Related Devices (Code: DWP)

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.

K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.K163524Vessel DilatorFetzer Medical GmbH & Co. KGK130896VASCULAR PROBE, VASCULAR PROBE ESSynovis Life Technologies, Inc.K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSGeister Medizin Technik GmbH

Official Source

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

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