510(k) K895367 ยท FPA Set, Administration, Intravascular
INTRAVENOUS EXTENSION SET
| Applicant | Medical Product Specialists, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 6, 1989 |
| Received | Aug 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Medela Inc Brand Name: Medela
Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN
Model/Catalog Number: ENF060182LD / 101033086
Software Version: N/A
Product Description: Enteral Extension Set, Length 60 Orange- Open, Classified |
FPA | None listed |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.