URESIL DILATOR WITH RADIOPAQUE MARKER— 510(k) K980282
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K980282 for URESIL DILATOR WITH RADIOPAQUE MARKER, Substantially Equivalent on 1998-04-24. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
Recent devices under product code DRE
view allMore clearances from Uresil Corp.
view all- K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
- K980278 — URESIL VASCU-FLO INFUSION CATHETER
- K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
- K980889 — URESIL NEPHRO-URETERAL STENT
- K972582 — URESIL GUIDEWIRE
Adverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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.