PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5

Source, Brachytherapy, Radionuclide

ISORAY MEDICAL, INC.

The following data is part of a premarket notification filed by Isoray Medical, Inc. with the FDA for Proxcelan Cs-131 Preloaded Braided Strands, Model: Pl-5.

Pre-market Notification Details

• Device ID: K092136
• 510k Number: K092136
• Device Name: PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
• Classification: Source, Brachytherapy, Radionuclide
• Applicant: ISORAY MEDICAL, INC. 350 HILLS ST., SUITE 106 Richland, WA 99354 -5411
• Contact: Fred Swindler
• Correspondent: Fred Swindler; ISORAY MEDICAL, INC. 350 HILLS ST., SUITE 106 Richland, WA 99354 -5411
• Product Code: KXK
• CFR Regulation Number: 892.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-15
• Decision Date: 2009-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860011485445	K092136	000
00860000064590	K092136	000