Fast-Cath Intra-Cardiac Introducer
FDA 510(k) K982187 · Daig Corp.
510(k) numberK982187
Submission
- Device name
- Fast-Cath Intra-Cardiac Introducer
- Applicant
- Daig Corp.
Minnetonka, MN, US - Received
- June 22, 1998
- Decision date
- September 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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More from Protaryx Medical, 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 |
| 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 |
| K942379 | Daig Diagnostic Electrophysiology CatheterDRF · Traditional | 12/27/1994SE |
Questions and answers
When was Fast-Cath Intra-Cardiac Introducer cleared by the FDA?
Fast-Cath Intra-Cardiac Introducer (K982187) received a 510(k) decision of Substantially Equivalent on September 16, 1998, 86 days after the submission was received.
What is the product code of K982187?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.