Tec Rotating Dual Hemovalve
FDA 510(k) K912664 · Intensive Technology, Inc.
510(k) numberK912664
Submission
- Device name
- Tec Rotating Dual Hemovalve
- Applicant
- Intensive Technology, Inc.
San Diego, CA, US - Received
- June 18, 1991
- Decision date
- August 24, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | 01/13/1993SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K903463 | Ivt Introducer SheathDYB · Traditional | 01/03/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | 06/22/1989SE |
| K890515 | Peripheral Atherectomy SystemDWX · Traditional | 05/23/1989SE |
| K882804 | 0.014 Peripheral Guide WireDQX · Traditional | 10/28/1988SE |
Questions and answers
When was Tec Rotating Dual Hemovalve cleared by the FDA?
Tec Rotating Dual Hemovalve (K912664) received a 510(k) decision of Substantially Equivalent on August 24, 1992, 433 days after the submission was received.
What is the product code of K912664?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.