FDA 510(k)

IRIDIUM 192 WIRES & PINS

K-Number: K771878 · 1977-10-27

Decision Date1977-10-27

Product CodeIWA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IRIDIUM 192 WIRES & PINS is the device name listed in this FDA 510(k) record. The listed applicant is Cis Radiopharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-10-27 under 510(k) number K771878. The device is classified under product code IWA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIDIUM 192 WIRES & PINS?

IRIDIUM 192 WIRES & PINS is a medical device that received FDA 510(k) clearance on 1977-10-27. The listed applicant is Cis Radiopharmaceuticals, Inc.. The 510(k) number is K771878.

When did IRIDIUM 192 WIRES & PINS receive FDA 510(k) clearance?

IRIDIUM 192 WIRES & PINS received FDA 510(k) clearance on 1977-10-27, under 510(k) number K771878.

Who is the listed applicant for IRIDIUM 192 WIRES & PINS?

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

What is the FDA product code for IRIDIUM 192 WIRES & PINS?

The FDA product code for IRIDIUM 192 WIRES & PINS is IWA.

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Other records listing Cis Radiopharmaceuticals, Inc. as applicant

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Related Devices (Code: IWA)

K915253IR-192 IMPLANT, MODIFICATIONOmnitron Intl., Inc.K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.K874895IR-192 IMPLANTRads S.L., Inc.K850382IRIDIUM SEEDSRadiation Safety & Nuclear Products, Inc.K844248IR-192 IMPLANTRads S.L., Inc.K850726WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.

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.