Product code DTJ— Cardiovascular
BAXTER HANDLE MODEL 1150
- Classification name
- Holder, Heart-Valve, Prosthesis
- Device class
- Class 1
- Regulation
- 21 CFR 870.3935
- Advisory panel
- Cardiovascular
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code DTJ
FDA has cleared devices under product code DTJ between 1979 and 1996, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1995
- 1994
- 1988
- 1987
- 1986
- 1981
- 1979
Top applicants under product code DTJ
Recent clearances under product code DTJ
- K962154 — CARBOMEDICS HANDLE
- K960169 — CARBOMEDICS VALVE TESTER
- K944214 — BAXTER HANDLE MODEL 1150
- K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
- K880052 — EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
- K871596 — IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
- K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
- K813276 — IONESCU-SHILEY VALVE HOLDER & HANDLE
- K811235 — DISPOSABLE HOLDER FOR HANCOCK MITRAL
- K811236 — DISPOSABLE HOLDER FOR HANCOCK AORTIC
- K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER
- K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.