RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER— 510(k) K001143
Substantially EquivalentRochester Medical Corp.
FDA 510(k) clearance K001143 for RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER, Substantially Equivalent on 2000-07-07. Applicant: Rochester Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Rochester Medical Corp.
- Product code
- Code MJC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stewartville, MN, US
Recent devices under product code MJC
view allMore clearances from Rochester Medical Corp.
view all- K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER
- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
- K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
- K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER
- K970704 — PERSONAL CATHETER
Adverse events under product code MJC
product code MJC- Injury
- 398
- Malfunction
- 12,582
- Other
- 2
- Total
- 12,982
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.