Panels › Cardiovascular › Product code OEQ · Class 2
Angiography/Angioplasty Kit
Regulation 870.1650
0510(k)s in 12 months (0 all time)
19recalls in 12 months (91 all time)
6recalls that name a 510(k)
Top companies in OEQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2020 | Merit Medical Systems, Inc. Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105
For Angiography/angioplasty.
The contents of the kit are surgical drapes, gowns, towe Terminated |
OEQ | None listed |
| Nov 10, 2020 | Merit Medical Systems, Inc. Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121
For Angiography/angioplasty.
The contents of the kit include surgical drapes, towe Terminated |
OEQ | None listed |
| Nov 10, 2020 | Merit Medical Systems, Inc. Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803
For Angiography/angioplasty.
The contents of the kit include surgical drapes, towels, medicine cup Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good produ Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Managemen Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management f Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Manageme Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Managemen Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management fi Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Manag Terminated |
OEQ | None listed |
| Sep 14, 2020 | Medline Industries Inc Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management f Terminated |
OEQ | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OEQ | None listed |
| Oct 26, 2018 | Merit Medical Systems, Inc. Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409 Terminated |
OEQ | None listed |
| Jul 9, 2018 | Merit Medical Systems, Inc. ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 0543 Terminated |
OEQ | None listed |
| Jan 18, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management
and/or Invasive Pressure Monitoring systems. Terminated |
OEQ | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900796
FEMORAL ANGIOGRAPHY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, et Terminated |
OEQ | K902191 |
| Sep 3, 2015 | Customed, Inc FEMORAL ANGIOGRAPHY PACK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | K902191 |
| Sep 3, 2015 | Customed, Inc ANGIOGRAPHY PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | K904694 |
| Sep 3, 2015 | Customed, Inc ANGIOGRAPHY PACK CUSTOMED 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | K904694 |
| Sep 3, 2015 | Customed, Inc ANGIOGRAPHY PK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | None listed |
| Sep 3, 2015 | Customed, Inc ANGIOGRAPHY PK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | K904694 |
| Sep 3, 2015 | Customed, Inc ANGIODRAPE PK 4/CS
Used by medical staff to perform surgical procedures and patient care
procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | K904694 |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683.
NAMIC Convenience Kits are intended to b Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
NAMIC Convenience Kits are Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kit Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits are Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits ar Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Femoral Angiography Pack, Catalog number 900-796.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Angiography Pack, Catalog number 900-610.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Angiography Pack, catalog #900-210
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Angiography Pack, Catalog number 900-2038.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Angiography Pack, Catalog number 900-1488.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Dec 16, 2014 | Customed, Inc Angiodrape Pack, Catalog number 900-002.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc ANGIOGRAPHY PACK
CONTENTS:
(4) CLOTH HUCK TOWEL BLUE
(1) TABLE COVER REINFORCED 50" x 90" LIF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF
(2) UTILITY BOWL 32oz LIF
(1) EME Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc ANGIOGRAPHY PACK -
(1) LINE H.P. 1200 PSI 48" M/F
(1) ANG. FEMORAL DRAPE WITH POUCH UF
(1) PLATFORM TRAY LARGE
(3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
( Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc FEMORAL ANGIOGRAPHY PACK -
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF
(1) TOWEL ABSORBENT 15" X 20" UF
(1) DRAPE ANGlO 75" X 145"
(4) TOWELS CLOTH HUCK (BLUE Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc ANGIOGRAPHY PACK -
( 1) FEMORAL ANGlO. DRAPE WITH POUCH
(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF
(2) NEEDLE HYPODERMIC 21G X 1%
( 1) TABLE COVER REINFORCED 44" X 78" LIF
(30) GAUZE SPONGES 4" X 4" Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc ANGIOGRAPHY PACK- -
(4) CLOTH HUCK TOWEL BLUE UF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF
(2) MEDICINE CUP 2oz. LIF
(3) UTILITY BOWL 32oz UF
(1) EMESIS BA Terminated |
OEQ | None listed |
| Aug 29, 2014 | Customed, Inc Customed Angiodrape Pack
convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table Terminated |
OEQ | None listed |
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