HARMAC MEDICAL PRODUCTS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1317547	1317547	HARMAC MEDICAL PRODUCTS, INC.	1	N	2026-01-01	2201 BAILEY AVE. BUFFALO NY US 14211

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
30926	1125687753	K950895	HARMAC EXTENSION INFUSION SET	FPA	1995-09-01
30926	1100409920	K090736	POWER INFUSER, MODEL M100B-3A	FRN	2009-05-20
30926	1909555748	K021916	HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001	FPA	2002-08-29
30926	1097775874
30926	1122363612
30926	1160671726
30926	1197907463
30926	1199068379
30926	1225478811
30926	1228009636
30926	1245128592
30926	1275060911
30926	1289778915
30926	1455567536
30926	1501839381
30926	1601086310
30926	1620513586
30926	1742134329
30926	1748399735
30926	1764854710
30926	1854188098
30926	1911682876
30926	2002718243
30926	2048728848
30926	2069800030

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FPA	2	2002-08-29
FRN	1	2009-05-20

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
2002-08-29
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BALLOON WEDGE PRESSURE CATHETER
1997-10-16
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BALLOON ANGIOGRAPHIC CATHETER
1997-10-16
HARMAC MEDICAL PRODUCTS, INC.
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
1997-10-15
HARMAC MEDICAL PRODUCTS, INC.
HARMAC THERMODILUTION CATHETER
1997-08-14
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
1997-08-14
HARMAC MEDICAL PRODUCTS, INC.
HARMAC QUADPOLAR MAPPING PACING CATHETER
1997-06-25
HARMAC MEDICAL PRODUCTS, INC.
HARMAC EXTENSION INFUSION SET
1995-09-01
HARMAC MEDICAL PRODUCTS, INC.