510(k) K170024
- Device
- Y-Connector Kit
- Applicant
- SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
- 510(k) number
- K170024
- Product code
- DTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-03
- Date received
- 2017-01-03
- Regulation
- 870.4290
- Classification name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code DTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015-12-02 |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | 2014-12-22 |
| K140475 | ROTATING ADAPTERS | Merit Medical Systems, Inc. | 2014-04-16 |
| K131124 | COLIGN | Jilin Coronado Medical , Ltd. | 2013-08-28 |
| K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | Medtronic, Inc. | 2012-12-13 |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-10-12 |
| K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| K120069 | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | 2012-04-03 |
| K113148 | E-PASS | Synexmed(Shenzhen)Company Limited | 2012-02-28 |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | 2012-01-25 |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | 2012-01-20 |
| K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2012-01-12 |
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 |
| K100319 | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L | Merit Medical Systems, Inc. | 2010-04-28 |
Legacy Summary#
summary
FDA Review#
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