MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
FDA 510(k) clearance K103386 · decided 2011-02-11
Clearance details
- K-number
- K103386
- Device name
- MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-18
- Decision date
- 2011-02-11
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # recall (Z-1564-2013) | Medtronic Inc. Cardiac Rhythm Disease Management | 2013-06-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S459) | Medtronic, Inc. | 2026-08-08 |
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| Sphere-9 Catheter AFR-00001 (P240013/S030) | Medtronic, Inc. | 2026-08-06 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S029) | Medtronic, Inc. | 2026-08-04 |
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| Aurora EV ICD (DVEA3E4) (P220012/S074) | Medtronic, Inc. | 2026-07-31 |
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S229) | Medtronic, Inc. | 2026-07-31 |