Panels › General, Plastic Surgery › Product code GBO · Class 1
Catheter, Nephrostomy, General & Plastic Surgery
Regulation 878.4200
0510(k)s in 12 months (11 all time)
0recalls in 12 months (8 all time)
2recalls that name a 510(k)
Top companies in GBO
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 0 | 7 |
| Angiomed U.S., Inc. | 5 | 0 |
| Uresil Corp. | 3 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 0 |
| Cook Inc. | 0 | 1 |
| Van-Tec, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2019 | Cook Inc. Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC Terminated |
GBO | None listed |
| Dec 12, 2017 | Boston Scientific Corporation Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the fo Terminated |
GBO | None listed |
| Dec 12, 2017 | Boston Scientific Corporation Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is i Terminated |
GBO | None listed |
| Dec 12, 2017 | Boston Scientific Corporation Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is i Terminated |
GBO | None listed |
| Dec 12, 2017 | Boston Scientific Corporation Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated f Terminated |
GBO | None listed |
| Dec 12, 2017 | Boston Scientific Corporation Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261
The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated f Terminated |
GBO | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001225240 VTC FIRM KIT 8
M001225140 VTC FIR Terminated |
GBO | K820867 |
| Jul 20, 2004 | Boston Scientific Corp Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; mode Terminated |
GBO | K820867 |
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