510(k) K031398
- Device
- IS-1 HEMOSTASIS VALVE, MODEL 6799
- Applicant
- Guidant Corp.
- 510(k) number
- K031398
- Product code
- DTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-20
- Date received
- 2003-05-05
- Regulation
- 870.4290
- Classification name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Colleen McCarter Bloom
- Address
- 4100 Hamline Ave. N St Paul MN US 55112 55112
FDA Registration Numbers#
- 1123137
- 3008403546
- 9680794
- 3005595283
- 3010872792
- 3031571797
- 3004091615
- 1060680
- 3007361214
- 2011171
- 1625425
- 1061124
- 3008002401
- 3012307300
- 3010432890
- 3012964172
- 3016950436
- 3010188783
- 3022815697
- 3002808466
- 3018167761
- 9612152
- 3015173212
- 3012536737
- 3004111573
- 1000121056
- 2939561
- 3015453963
- 2030624
- 8020785
- 2024168
- 1724474
- 3004519921
- 3033589330
- 2320762
- 1054241
- 3027815
- 3007830707
- 2124215
- 3005273623
- 1124841
- 3003932293
- 3038846851
- 3006181312
- 3008261722
- 3010141307
- 1718850
- 1450662
- 3002808467
- 9614279
- 2024024
- 9616662
- 3015910259
- 1928237
- 3006891665
- 3015309643
- 1319639
- 1649395
- 9610825
- 1037885
- 3008853977
- 1018470
- 1043214
- 1423395
- 2529846
- 3010273872
- 1820334
- 3011564431
- 1000533027
- 9616567
- 2027062
- 3009605245
- 3007835716
- 3006942524
- 3036802499
- 2182208
- 1000112137
- 3005012805
- 3011642792
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 |
| 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 |