HEMOCOR HPH 700 HEMOCONCENTRATOR— 510(k) K983085
Substantially EquivalentMinntech Corp.
FDA 510(k) clearance K983085 for HEMOCOR HPH 700 HEMOCONCENTRATOR, Substantially Equivalent on 1998-11-13. Applicant: Minntech Corp.. Device class: 2.
Clearance details
- Applicant
- Minntech Corp.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code KDI
view allMore clearances from Minntech Corp.
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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 →
Recalls naming K983085
K-number listed on FDA's recall record- Z-2735-2015 — MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
- Z-2761-2015 — Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983085.
Data sourced from openFDA. This site is unofficial and independent of the FDA.