Transvenous Balloon Tipped(Flow Directed) Temp. Pa
FDA 510(k) K844752 · Mansfield Scientific, Inc.
510(k) numberK844752
Submission
- Device name
- Transvenous Balloon Tipped(Flow Directed) Temp. Pa
- Applicant
- Mansfield Scientific, Inc.
Mansfield, MA, US - Received
- December 6, 1984
- Decision date
- January 2, 1985
- 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
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| 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 |
|---|---|---|
| K865017 | AngioscopeDQX · Traditional | 12/15/1987SE |
| K870186 | Endomyocardial Biopsy DeviceDWZ · Traditional | 02/20/1987SE |
| K855103 | Ciribart Gyudubg CatgeterDQO · Traditional | 02/18/1986SE |
| K853850 | ExplorerDTB · Traditional | 12/04/1985SE |
| K852797 | Heparin Coat Tran Ballo Tip Temp Pac ElectrodeLDF · Traditional | 09/16/1985SE |
| K851848 | Percutaneous Transluminal Blood Dilation CatheterLIT · Traditional | 07/19/1985SE |
| K841705 | Wedge Pressure Catheter Flow DirectedDYG · Traditional | 07/13/1984SE |
Questions and answers
When was Transvenous Balloon Tipped(Flow Directed) Temp. Pa cleared by the FDA?
Transvenous Balloon Tipped(Flow Directed) Temp. Pa (K844752) received a 510(k) decision of Substantially Equivalent on January 2, 1985, 27 days after the submission was received.
What is the product code of K844752?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.