Heparin Bonding for Catheters
FDA 510(k) K884697 · Daig Corp.
510(k) numberK884697
Submission
- Device name
- Heparin Bonding for Catheters
- Applicant
- Daig Corp.
Minnetonka, MN, US - Received
- November 9, 1988
- Decision date
- April 19, 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 |
|---|---|---|
| K000004 | Alliance Left Heart Delivery System Introducer, Model #407509DYB · Traditional | 11/29/2000SE |
| K994334 | Ultra-Flex Hemostasis Introducer. Model 406XXXDYB · Special | 05/15/2000SE |
| K982299 | Spyglass 5 FR Angiographic CatheterDQO · Traditional | 10/19/1998SE |
| K982187 | Fast-Cath Intra-Cardiac IntroducerDYB · Traditional | 09/16/1998SE |
| K973840 | Fast-Cath (TM) Intra-Cardiac IntroducerDYB · Traditional | 05/21/1998SE |
| K964518 | Fast-Cath Transseptal Catheter IntroducerDYB · Traditional | 05/14/1997SE |
| K965249 | Spyglass Angiographic CatheterDQO · Traditional | 02/21/1997SE |
| K962805 | Spyglass Angiographic CatheterDQO · Traditional | 10/15/1996SE |
| K954317 | Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/Sideports & 3-WAY StopcocksDYB · Traditional | 11/28/1995SE |
| K944284 | ControlDQO · Traditional | 03/03/1995SE |
Questions and answers
When was Heparin Bonding for Catheters cleared by the FDA?
Heparin Bonding for Catheters (K884697) received a 510(k) decision of Substantially Equivalent on April 19, 1989, 161 days after the submission was received.
What is the product code of K884697?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.