Catheter, Malecot
FDA product code FEW · Class II (moderate risk) · 21 CFR 876.5090 · Gastroenterology, Urology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140085 | Universa Percultaneous Drainage CatheterFEW · Traditional | Cook Incorporated | 11/18/2014SE |
| K070879 | Bard Malecot and Pezzer DrainsFEW · Special | C.R. Bard, Inc. | 04/24/2007SE |
| K981258 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Medical Device Technologies, Inc. | 04/22/1998SE |
| K954147 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Manan Medical Products, Inc. | 03/26/1996SE |
| K954116 | Silicone Malecot Catheter with Pezzer/Mushroom TipFEW · Traditional | Technical Products, Inc. | 11/06/1995SE |
| K920423 | Olympic Smart Scale Care CenterFEW · Traditional | Olympic Medical Corp. | 06/11/1992SE |