Cardiovascular Permanent Pacemaker Electrode
FDA 510(k) K920822 · Siemens-Pacesetter, Inc.
510(k) numberK920822
Submission
- Device name
- Cardiovascular Permanent Pacemaker Electrode
- Applicant
- Siemens-Pacesetter, Inc.
Sylmar, CA, US - Received
- February 24, 1992
- Decision date
- January 22, 1993
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTB – Permanent Pacemaker Electrode
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DTB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061212 | Biotronik Endocardial Pacing LeadsDTB · Special | Biotronik, Inc. | 07/10/2006SE |
| K041809 | Permanent Pacing Lead, Model PY2DTB · Special | Oscor, Inc. | 08/06/2004SE |
| K040569 | Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, RjuDTB · Special | Oscor, Inc. | 04/07/2004SE |
| K031274 | Model 5071 Myocardial Pacing LeadDTB · Special | Medtronic Vascular | 05/22/2003ST |
| K031210 | Model 4951M Myocardial Unipolar LeadDTB · Special | Metronic, Inc. | 05/16/2003SE |
| K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional | Biotronik, Inc. | 04/24/2003ST |
| K024053 | Permanent Pacing Leads, Models Physique PB and PJBDTB · Special | Oscor, Inc. | 01/31/2003SE |
| K023803 | Modification to Biotronik's Sterilization ProcessDTB · Special | Biotronik, Inc. | 12/11/2002SE |
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | Biotronik, Inc. | 10/18/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | Biotronik, Inc. | 05/01/2002SE |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942440 | Afp Cardiac Pacing System Model 283DTB · Traditional | 08/08/1994ST |
| K925038 | Pacing Lead Model 1188TDTB · Traditional | 07/15/1994ST |
| K932892 | Passive Plus Endocardial Pacing Leads Var. ModelsDTB · Traditional | 07/06/1994SESP |
| K930876 | Silicone Bipolar Lead Models 1136T, 1142T &1146TDTB · Traditional | 06/15/1994ST |
| K925347 | Model 1148T Transvenous, Screw-In LeadDTB · Traditional | 06/10/1993SE |
| K921318 | Adapting Sleeve Kit Model 4023DTD · Traditional | 08/03/1992SE |
Questions and answers
When was Cardiovascular Permanent Pacemaker Electrode cleared by the FDA?
Cardiovascular Permanent Pacemaker Electrode (K920822) received a 510(k) decision of Unknown on January 22, 1993, 333 days after the submission was received.
What is the product code of K920822?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.