FDA 510(k) Applications Submitted by Nancy Teague

FDA 510(k) Number Submission Date Device Name Applicant
K223463 11/16/2022 Otsuka Digital Feedback Device-RW Otsuka America Pharmaceutical, Inc.
K970938 03/13/1997 HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING BIOCOMPATIBLES CARDIOVASCULAR, INC.
K961232 03/29/1996 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP BIOCOMPATIBLES LTD.
K942227 05/06/1994 NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM C.L. MCINTOSH & ASSOC., INC.
K962266 06/12/1996 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING BIOCOMPATIBLES CARDIOVASCULAR, INC.
K962717 07/12/1996 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING BIOCOMPATIBLES CARDIOVASCULAR, INC.
K955135 11/09/1995 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING BIOCOMPATIBLES LTD.


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