510(k) K082758 ยท KOC Accessories, Blood Circuit, Hemodialysis
PRISMAFLO II
| Applicant | Stihler Electronic GmbH, Sound Beach NY, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Sep 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II S blood return warmer for Prismaflex
Product Code: PF2-WP33
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | None listed |
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II S blood return warmer for
Prismaflex
Product Code: PF2-WP31
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | None listed |
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II blood return warmer for
Prismaflex
Product Code: PF2-WP2618
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.