Microcruiser Plus Introducer Set
FDA 510(k) K011790 · Medical Device Technologies, Inc.
510(k) numberK011790
Submission
- Device name
- Microcruiser Plus Introducer Set
- Applicant
- Medical Device Technologies, Inc.
Gainesville, FL, US - Received
- June 8, 2001
- Decision date
- September 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
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Questions and answers
When was Microcruiser Plus Introducer Set cleared by the FDA?
Microcruiser Plus Introducer Set (K011790) received a 510(k) decision of Substantially Equivalent on September 5, 2001, 89 days after the submission was received.
What is the product code of K011790?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.