SHILEY CARDIOTOMY RESERVOIR W/FILTER— 510(k) K801375
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K801375 for SHILEY CARDIOTOMY RESERVOIR W/FILTER, Substantially Equivalent on 1980-07-14. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code DTP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code DTP
view all- K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
- K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K002591 — COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
More clearances from Shiley, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.