Lead Stylet,Models 6505,6506,6507,6508
FDA 510(k) K992863 · Guidant Corp.
510(k) numberK992863
Submission
- Device name
- Lead Stylet,Models 6505,6506,6507,6508
- Applicant
- Guidant Corp.
St Paul, MN, US - Received
- August 25, 1999
- Decision date
- November 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
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| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
| K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional | St Jude Medical | 04/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 04/30/2008SE |
| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 03/13/2008SE |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | Guidant Corporation | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | Guidant Corporation | 02/13/2006SE |
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| K061865 | Flex 10 Mis Ablation Probe, Model FLX10MI-05NEY · Special | 07/27/2006SE |
| K061453 | Hi-Torque Whisper View Guide WireDQX · Special | 06/22/2006SE |
| K060449 | Hi-Torque Advance and Advance Lite Guide WireDQX · Traditional | 05/30/2006SE |
| K053459 | Omnilink .035 Biliary Stent SystemFGE · Traditional | 04/12/2006SESU |
| K053454 | RX Herculink Elite Biliary Stent SystemFGE · Traditional | 03/06/2006SESU |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | 02/13/2006SE |
| K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000GEI · Special | 09/21/2005SE |
| K052166 | Modification to: RX Accunet Embolic Protection SystemNTE · Special | 08/18/2005SE |
| K052165 | RX Accunet Embolic Protection SystemNTE · Special | 08/16/2005SE |
Questions and answers
When was Lead Stylet,Models 6505,6506,6507,6508 cleared by the FDA?
Lead Stylet,Models 6505,6506,6507,6508 (K992863) received a 510(k) decision of Substantially Equivalent on November 12, 1999, 79 days after the submission was received.
What is the product code of K992863?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.