510(k) K080924
- Device
- MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
- Applicant
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- 510(k) number
- K080924
- Product code
- DRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-30
- Date received
- 2008-04-02
- Regulation
- 870.1380
- Classification name
- Stylet, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN CANAN
- Address
- 15900 Valley View Ct. Sylmar CA US 91342 91342
FDA Registration Numbers#
- 1028232
- 3005029049
- 1721686
- 2649622
- 3007284006
- 2017865
- 3009211636
- 2124215
- 2522007
- 1721676
- 3033536312
- 1721504
- 9680794
- 3012552532
- 1644312
- 1724474
- 1000393132
- 9610849
- 3013162291
- 2030624
- 2032521
- 9616662
- 1649395
- 9610139
- 1293141
- 1222301
- 3011137372
- 3036802499
- 1319639
- 3015859709
- 3000126629
- 1282497
- 3010041511
- 3004365956
- 3010291427
Source Documents#
Other 510(k) Records For Product Code DRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 |
| K191469 | Biotronik Stylets | Biotronik, Inc. | 2019-08-01 |
| K182660 | GaltTWS | Galt Medical Corp. | 2019-05-30 |
| K170298 | Liberator Beacon Tip Locking Stylet | Cook Incorporated | 2017-10-18 |
| K142116 | LLD EZ | Spectranetics, Inc. | 2014-08-12 |
| K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | St Jude Medical | 2009-04-01 |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Guidant Corporation | 2006-03-03 |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Guidant Corporation | 2006-02-13 |
| K043401 | SPECTRANETICS LLD CS, MODEL 518-039 | Spectranetics Corp. | 2005-03-16 |
| K040001 | STEERABLE STYLET | Synovis Surgical Innovations | 2004-03-09 |
| K010906 | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | Medtronic Vascular | 2001-04-05 |
| K003535 | STYLET KIT, MODELS 6254,6282,6293 | Medtronic Vascular | 2001-02-08 |
| K002534 | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | Eupalamus, LLC | 2000-10-18 |
| K000955 | PLACER MODEL 6232 STEERABLE STYLET | Medtronic Vascular | 2000-06-16 |
Legacy Summary#
summary
FDA Review#
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