Torque Hex Wrench
FDA 510(k) K875147 · Cardiac Pacemakers, Inc.
510(k) numberK875147
Submission
- Device name
- Torque Hex Wrench
- Applicant
- Cardiac Pacemakers, Inc.
St. Paul, MN, US - Received
- December 15, 1987
- Decision date
- January 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTF – Tools, Pacemaker Service
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3730
- Specialty
- Cardiovascular
Other 510(k)s with product code DTF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781179 | Wrench, Gexagon, DriverDTF · Traditional | Telectronics, Inc. | 07/27/1978SE |
More from Telectronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093969 | Acuity Break-Away Guide CatheterDQY · Special | 03/05/2010SE |
| K080154 | Acuity Universal CutterDQY · Special | 03/20/2008SE |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K920601 | Astra T2, Astra T4, Astra T6DXY · Traditional | 10/28/1992SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K872774 | Betatron IV SystemFRN · Traditional | 01/05/1988SE |
Questions and answers
When was Torque Hex Wrench cleared by the FDA?
Torque Hex Wrench (K875147) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 43 days after the submission was received.
What is the product code of K875147?
The FDA product code is DTF – Tools, Pacemaker Service, a Class I (low risk) device regulated under 21 CFR 870.3730.