MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
FDA 510(k) clearance K030209 · decided 2003-05-13
Clearance details
- K-number
- K030209
- Device name
- MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
- Applicant
- The Kendall Company
- Decision
- Substantially Equivalent
- Date received
- 2003-01-21
- Decision date
- 2003-05-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Kendall Company
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only recall (Z-0877-2023) | Covidien LP | 2023-01-12 |
| Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemo recall (Z-0233-04) | Kendall Healthcare Products Co | 2003-12-17 |
| Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5 recall (Z-0234-04) | Kendall Healthcare Products Co | 2003-12-17 |