TYSHAK NUCLEUS

Catheter, Percutaneous

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Tyshak Nucleus.

Pre-market Notification Details

• Device ID: K121859
• 510k Number: K121859
• Device Name: TYSHAK NUCLEUS
• Classification: Catheter, Percutaneous
• Applicant: NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965
• Contact: Nichelle Laflesh
• Correspondent: Nichelle Laflesh; NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-26
• Decision Date: 2012-08-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04046964511950	K121859	000
04046964511752	K121859	000
04046964511745	K121859	000
04046964511738	K121859	000
04046964511721	K121859	000
04046964511714	K121859	000
04046964511707	K121859	000
04046964511691	K121859	000
04046964511684	K121859	000
04046964511677	K121859	000
04046964511660	K121859	000
04046964511653	K121859	000
04046964511646	K121859	000
04046964511639	K121859	000
04046964511622	K121859	000
04046964511615	K121859	000
04046964511608	K121859	000
04046964511769	K121859	000
04046964511776	K121859	000
04046964511783	K121859	000
04046964511943	K121859	000
04046964511936	K121859	000
04046964511929	K121859	000
04046964511912	K121859	000
04046964511905	K121859	000
04046964511899	K121859	000
04046964511882	K121859	000
04046964511875	K121859	000
04046964511868	K121859	000
04046964511851	K121859	000
04046964511844	K121859	000
04046964511837	K121859	000
04046964511820	K121859	000
04046964511813	K121859	000
04046964511806	K121859	000
04046964511790	K121859	000
04046964511493	K121859	000