Enstylet Models EC0010, EC0020
FDA 510(k) K993376 · Endocardial Solutions, Inc.
510(k) numberK993376
Submission
- Device name
- Enstylet Models EC0010, EC0020
- Applicant
- Endocardial Solutions, Inc.
St. Paul, MN, US - Received
- October 7, 1999
- Decision date
- January 5, 2000
- 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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More from Guidant Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K042493 | Ensite System, Model EE3000DQK · Special | 10/15/2004SE |
| K033211 | Ensite SystemDQK · Special | 10/30/2003SE |
| K030129 | Modification to Ensite 3000 System, Model EE3000DQK · Traditional | 04/22/2003SESU |
| K012926 | Modification to Ensite 3000 System, Model EE3000MTD · Special | 09/28/2001SESU |
| K001437 | Ensite 3000 System, Model EE3000DQK · Special | 06/07/2000SE |
| K992479 | Ensite 3000 SystemDQK · Traditional | 12/02/1999SESU |
| K983456 | Ensite 3000 SystemMTD · Traditional | 04/21/1999SESU |
Questions and answers
When was Enstylet Models EC0010, EC0020 cleared by the FDA?
Enstylet Models EC0010, EC0020 (K993376) received a 510(k) decision of Substantially Equivalent on January 5, 2000, 90 days after the submission was received.
What is the product code of K993376?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.