Panels › Cardiovascular › Product code OFA · Class 1
Cardiovascular Surgical Instruments Tray
Regulation 870.4500
0510(k)s in 12 months (0 all time)
0recalls in 12 months (21 all time)
4recalls that name a 510(k)
Top companies in OFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 18 |
| Centurion Medical Products Corporation | 0 | 2 |
| Maquet Cardiovascular, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 9002618
OPEN HEART SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | K904693 |
| Sep 3, 2015 | Customed, Inc OPEN HEART PACK 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | K904693 |
| Sep 3, 2015 | Customed, Inc OPEN HEART TRAY CUSTOMED 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | K904693 |
| Sep 3, 2015 | Customed, Inc OPEN HEART TRAY 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | K904693 |
| Sep 3, 2015 | Customed, Inc OPEN HEART TRAY 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | None listed |
| Jan 8, 2015 | Centurion Medical Products Corporation Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) Terminated |
OFA | None listed |
| Jan 8, 2015 | Centurion Medical Products Corporation Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Open Heart Pack, catalog #900-2618
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Open Heart Tray, Catalog number 900-170.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Cirugia Cardiovascular Case Cart, Catalog number 900-1500.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Cirugia Cardiovascular Case Cart, Catalog number 900-1415A.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Open Heart Tray, Catalog number 900-1393.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Dec 16, 2014 | Customed, Inc Open Heart Tray, Catalog number 900-1196C
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains:
(1) CIRUGIA CARDIOVASCULAR .(INDUCCION)
(1) CIRUGIA CARDIOVASCULAR (CIRUGIA )
(1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA
CIRCULANTE)
(1) CI Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc Open Heart Tray, Pack A, code 900-1196C, contains:
(1) TABLE COVER REINFORCED L/Free
(1) CARDIOVASCU.LAR INCISE DRAPE L/Free
(2) 3/4 ABS. REINFORCED SHEET
(1) PLASTIC SHEET
(5) DRAPE SHEET SMS
(18) CL Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc Endovascular Pack, code 900-2715, contains:
( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF
(2) TOWELS ABSORBENT 15 X 20 LIF
( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf
(2) BAG BAND FLUOROSCOPE Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc Open Heart Pack, code 900-2618, contains:
(9) DRAPE 60" X 76" REINFORCED LIF
( 1) MAYO STAND COVER REINFORCED LIF
(6) TOWELS ABSORBENT 15" X 20" L/F
( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LI Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc OPEN HEART TRAY
PACK A
CONTENTS:
(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F
(3) TOWEL ABSORBENT 15" X 20" LIF
(1) TABLE COVER REINFORCED 50" X 90" LI Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc OPEN HEART TRAY - - PACK A
( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF
(5) DRAPE % ECONOMY 53" X 77" LIF
( 1) MAYO STAND COVER REINFORCED LIF
(7) DRAPE UTILITY WITH TAPE L/F
(8) HUCK CLOTH Terminated |
OFA | None listed |
| Aug 29, 2014 | Customed, Inc OPEN HEART TRAY - PACK-
(25) SPONGE LAP PREWASH 18" X 18" XRD L/F
(1) TRAY PLATO LARGE
(3) DRESSING NON ADH TELFA 8 X 3
(2) BAG GLASSINE PLAIN
(2) YANKAUER SUCTION TUBE WITHOUT VENT LIF
(1) COVE Terminated |
OFA | None listed |
| Oct 1, 2013 | Maquet Cardiovascular, LLC Ultima OPCAB System, Sterile, Rx Only,
Product Usage:
Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform Terminated |
OFA | None listed |
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