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FDA 510(k) Applications Submitted by NANCY F 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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