510(k) K900652
- Device
- NAMIC PTCA Y-ADAPTOR
- Applicant
- NORTH AMERICAN INSTRUMENT CORP.
- 510(k) number
- K900652
- Product code
- DTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-26
- Date received
- 1990-02-09
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- E FRANKLIN
- Address
- Glens Falls NY US 12801 12801
FDA Registration Numbers
- 1450662
- 3014499739
- 3016950436
- 2521402
- 3012050423
- 1625519
- 3022815697
- 1061124
- 9616662
- 2027062
- 3006210673
- 2032677
- 3011564431
- 3015453963
- 3008002401
- 3010291427
- 3018167761
- 1037885
- 3012536737
- 3004122598
- 1644312
- 1018470
- 3006223010
- 3031571797
- 1718873
- 3005012805
- 2648727
- 3013557562
- 2024168
- 3010141307
- 9616684
- 1423537
- 1721676
- 1820334
- 2939561
- 3015910259
- 3038846851
- 3036802499
- 1718850
- 3006425876
- 3006950086
- 3012307300
- 3033589330
- 3006891665
- 3013298431
- 3017636737
- 2024024
- 3002807314
- 3004194523
- 3009605245
- 3008403546
- 3010872792
- 1423395
- 3006181312
- 9612152
- 1422634
- 1625425
- 3006942524
- 2184009
- 1043214
- 3004198398
- 3003955307
- 9614279
- 1055236
- 3018312328
- 3015173212
- 3012964172
- 3011826338
- 1417592
- 1649914
- 1928237
- 2529846
- 1724474
- 3007836437
- 1319639
- 3010188783
- 9610825
- 3004091615
- 3007361214
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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FDA Review
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