SILICONE ANTIBACTERIAL FOLEY CATHETER— 510(k) K971627
Substantially EquivalentRochester Medical Corp.
FDA 510(k) clearance K971627 for SILICONE ANTIBACTERIAL FOLEY CATHETER, Substantially Equivalent on 1998-01-13. 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
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- K040658 — BARDEX I.C. LATEX FOLEY CATHETER
- K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- K000251 — SPECTRUM SILICONE FOLEY CATHETER
- K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
More 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
- K970704 — PERSONAL CATHETER
- K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL 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.