510(k) K870073
- Device
- Manifold Swivel Rotator Models 014320 & 014321-tab
- Applicant
- CLINICAL CONNECTIONS, INC.
- 510(k) number
- K870073
- Product code
- DTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-20
- Date received
- 1987-01-08
- 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
- KEITH ANTAL
- Address
- P.O. Box 238 9287 Smucker Rd. Orrville OH US 44667 44667
FDA Registration Numbers#
- 1724474
- 3010432890
- 2529846
- 3004519921
- 3007835716
- 3012307300
- 3006425876
- 9680794
- 1625519
- 3006181312
- 3004111573
- 3015910259
- 3012536737
- 9612152
- 3011564431
- 2011171
- 3044778332
- 3010188783
- 9616088
- 3003955307
- 9616684
- 3011137372
- 3045816907
- 1043214
- 3011826338
- 3002808467
- 9614279
- 3018312328
- 3008403546
- 2134812
- 3036802499
- 3007836437
- 2184009
- 3011237770
- 3007138831
- 1423395
- 3027637845
- 3014499739
- 3012964172
- 3012776242
- 1721504
- 9616662
- 3004859241
- 9610825
- 1319639
- 1220452
- 2024024
- 1018470
- 1054241
- 3010141307
- 3017987980
- 3009291251
- 1048735
- 1721676
- 1718850
- 3034544377
- 2939561
- 3003898360
- 3015453963
- 2030624
- 3002808466
- 1055236
- 1422634
- 1928237
- 3008853977
- 3007289408
- 3003932293
- 2182208
- 1037885
- 3010872792
- 3008500478
- 3033589330
- 1450662
- 3010273872
- 3015173212
- 3008361782
- 1000533027
- 1000112137
- 1423537
- 3008261722
Source Documents#
510(k) summary PDF not indicated by FDA
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| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 |
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