Myocardial Lead Implant Tool, Model 10626
FDA 510(k) K022238 · Medtronic Vascular
510(k) numberK022238
Submission
- Device name
- Myocardial Lead Implant Tool, Model 10626
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- July 11, 2002
- Decision date
- October 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
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| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 09/13/1989SE |
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Questions and answers
When was Myocardial Lead Implant Tool, Model 10626 cleared by the FDA?
Myocardial Lead Implant Tool, Model 10626 (K022238) received a 510(k) decision of Substantially Equivalent on October 9, 2002, 90 days after the submission was received.
What is the product code of K022238?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.