510(k) K924163
- Device
- EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K924163
- Product code
- DRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-03
- Date received
- 1992-08-19
- Regulation
- 870.1220
- Classification name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- M CARPINELLA
- Address
- 2710 Orchard Pkwy. San Jose CA US 95134 95134
FDA Registration Numbers
- 1028232
- 3011610434
- 9617601
- 2024311
- 2029275
- 2024024
- 2135338
- 2528981
- 3008093809
- 1927197
- 3010532612
- 1000121056
- 2184009
- 2648623
- 3003289723
- 3013162291
- 2032112
- 3008452825
- 3010705768
- 9610139
- 3011276773
- 1319639
- 2126666
- 1018233
- 3003678543
- 1928237
- 2182208
- 1225687
- 1721686
- 1313046
- 2030404
- 3008497357
- 3027305778
- 3010273872
- 3013403214
- 2124215
- 9617592
- 3025341484
- 1643817
- 3007616088
- 3010200163
- 3015859709
- 3018258443
- 3017060084
- 1061124
- 3004859241
- 1650907
- 3016678045
- 3009888344
- 9680001
- 3009337690
- 3014368660
- 3019807891
- 3011024991
- 2028523
- 3005402529
- 3006082230
- 1317547
- 1721983
- 3009243923
- 3027815
- 3008824097
- 9681260
- 3019751610
- 3005334138
- 2032098
- 3015537323
- 9673241
- 3006634485
- 2183744
- 2182269
- 2649622
- 2184149
- 3009254201
- 1450662
- 8043831
- 1721676
- 9680794
- 3009393076
- 3013400708
Source Documents
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| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | 2022-01-26 |
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Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases