Product code FLD— Gastroenterology, Urology
HEMOPERFUSION SYSTEM TP-400
- Classification name
- Apparatus, Hemoperfusion, Sorbent
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code FLD
FDA has cleared devices under product code FLD between 1983 and 2014, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 2012
- 2005
- 1999
- 1997
- 1996
- 1989
- 1987
- 1984
- 1983
Top applicants under product code FLD
Recent clearances under product code FLD
- K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
- K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS)
- K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
- K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
- K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
- K971015 — AHCS HEMOPERFUSION SYSTEM
- K953751 — BIOLOGIC-DT SYSTEM
- K885017 — HEMOSORBA CH-500, CH-350 AND CH-180
- K873643 — GAMBRO ADSORBA 150C
- K840532 — HEMOPERFUSION SYSTEM TP-400
- K831029 — HEMOPERFUSION SYSTEM TP-400
Data sourced from openFDA. This site is unofficial and independent of the FDA.