510(k) K233094
- Device
- Wellead® Latex Foley Catheter
- Applicant
- Well Lead Medical (Hainan) Co., Ltd.
- 510(k) number
- K233094
- Product code
- MJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-06
- Date received
- 2023-09-26
- Regulation
- 876.5130
- Classification name
- Catheter, Urological (Antimicrobial) And Accessories
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jenny Zhu
- Address
- # 39, Mei'An 3rd St., Mei'An Ecological Science Park Haikou CN 571157 571157
FDA Registration Numbers#
- 8040607
- 3006082230
- 9611590
- 1018233
- 1054241
- 3027301746
- 2032098
- 1055236
- 2320762
- 1043214
Source Documents#
Other 510(k) Records For Product Code MJC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | C.R. Bard, Inc. | 2004-09-29 |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Rochester Medical Corp. | 2004-06-10 |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | 2000-08-30 |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Rochester Medical Corp. | 2000-07-07 |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | C.R. Bard, Inc. | 1999-12-10 |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Bard Medical Div. | 1999-02-16 |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | C.R. Bard, Inc. | 1998-11-03 |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Rochester Medical Corp. | 1998-01-13 |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | C.R. Bard, Inc. | 1994-08-18 |