510(k) K884200
- Device
- Usci Tandem Adapter
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K884200
- Product code
- DTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-05
- Date received
- 1988-10-06
- Regulation
- 870.4290
- Classification name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANICE PIASECKI
- Address
- 1200 Technology Park Dr. P.O. Box 7025 Billerica MA US 01821 01821
FDA Registration Numbers#
- 2184009
- 1417592
- 3044778332
- 3009380063
- 3004198398
- 3012050423
- 3012964172
- 3007361214
- 3004091615
- 1000121056
- 2029275
- 3004111573
- 1644312
- 1000533027
- 9610825
- 1423395
- 1820334
- 3004122598
- 3014499739
- 1718873
- 1643817
- 3007836437
- 9612152
- 1048735
- 3004605321
- 3022815697
- 1450662
- 3015309643
- 3011237770
- 3005012805
- 9617601
- 3027815
- 3010291427
- 3007289408
- 3006891665
- 1123137
- 3010872792
- 1220452
- 9680794
- 3005941719
- 3010273872
- 3004519921
- 3033589330
- 2024024
- 3008361782
- 3015225571
- 1724474
- 9616088
- 3010141307
- 3011642792
- 3007835716
- 2124215
- 1718850
- 9614279
- 3008853977
- 3011137372
- 3018312328
- 3036802499
- 1037885
- 3012536737
- 1000112137
- 2024168
- 3003955307
- 3016950436
- 3012776242
- 1061124
- 2320762
- 3034544377
- 3007830707
- 1721504
- 3015910259
- 2529846
- 2648727
- 1055236
- 9616567
- 1060680
- 3019807891
- 3018167761
- 2027062
- 3005273623
Source Documents#
510(k) summary PDF not indicated by FDA
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 |