MODIFICATION TO 30 EXTENSION SET— 510(k) K021395
Substantially EquivalentChurchill Medical Systems, Inc.
FDA 510(k) clearance K021395 for MODIFICATION TO 30 EXTENSION SET, Substantially Equivalent on 2002-05-13. Applicant: Churchill Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Churchill Medical Systems, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dover, NH, US
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Churchill Medical Systems, Inc.
view all- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K013950 — VENTED VIAL ACCESS DEVICE
- K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 K021395
K-number listed on FDA's recall record- Z-1484-2017 — AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Z-0787-2017 — AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
- Z-1467-2015 — 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
- Z-1468-2015 — Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
- Z-1469-2015 — 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
- Z-1470-2015 — 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
- Z-1471-2015 — 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
- Z-1472-2015 — 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
- Z-1473-2015 — 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
- Z-1474-2015 — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Z-1475-2015 — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Z-1476-2015 — Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
- Z-1477-2015 — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
- Z-1478-2015 — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
- Z-0813-2014 — AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021395.
Data sourced from openFDA. This site is unofficial and independent of the FDA.