510(k) K973477
- Device
- BIOSENSORS EMBOLECTOMY CATHETER
- Applicant
- SUNSCOPE INTL., INC.
- 510(k) number
- K973477
- Product code
- DXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-04
- Date received
- 1997-09-15
- Regulation
- 870.5150
- Classification name
- Catheter, Embolectomy
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- JOHN SHULZE
- Address
- 20250 Acacia St., Suite 115 Newport Beach CA US 92660 92660
FDA Registration Numbers
- 2024311
- 1018233
- 1061124
- 3013666218
- 2183870
- 9617465
- 2015691
- 3010041511
- 2183744
- 3035111606
- 2648045
- 2029386
- 9680794
- 3030714660
- 9615817
- 3008496528
- 8043983
- 2522007
- 3005704822
- 3006082230
- 3011137372
- 3032916632
- 1220452
- 1220948
- 1721504
- 1000393132
- 1820334
- 2027111
- 1721686
- 3015859709
- 1319639
- 3009051888
- 3012050423
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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