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510(k) K771878

IRIDIUM 192 WIRES & PINS by Cis Radiopharmaceuticals, Inc. — Product Code IWA

K771878 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "IRIDIUM 192 WIRES & PINS". The FDA issued a decision of Substantially Equivalent on October 27, 1977. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1977
Date Received
October 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Wire, Iridium, Radioactive
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 1976)

Other clearances for product code IWA

  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (September 29, 1989)
  • K874895 — IR-192 IMPLANT (February 25, 1988)
  • K850382 — IRIDIUM SEEDS (August 15, 1985)
  • K844248 — IR-192 IMPLANT (April 10, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)

FDA data resources