Siemens Elema Models 4025 and 4026 Adapters
FDA 510(k) K890547 · Pacesetter Systems
510(k) numberK890547
Submission
- Device name
- Siemens Elema Models 4025 and 4026 Adapters
- Applicant
- Pacesetter Systems
Sylmar, CA, US - Received
- February 3, 1989
- Decision date
- March 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | 08/28/1991SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | 07/17/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | 06/25/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | 04/20/1990SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | 12/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | 06/05/1989SE |
| K885267 | VS-1 Model Number 251K Pulse GeneratorDXY · Traditional | 03/28/1989SE |
| K884733 | Afp Model 262T Pulse GeneratorDXY · Traditional | 02/10/1989SE |
| K883087 | Prolog MP 658M Pulse GeneratorDXY · Traditional | 09/14/1988SE |
| K874205 | Endocardial Screw-In Lead, Model 1018TDTB · Traditional | 02/02/1988SE |
Questions and answers
When was Siemens Elema Models 4025 and 4026 Adapters cleared by the FDA?
Siemens Elema Models 4025 and 4026 Adapters (K890547) received a 510(k) decision of Substantially Equivalent on March 22, 1989, 47 days after the submission was received.
What is the product code of K890547?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.