Right Atrial Catheters
FDA 510(k) K911333 · Akcess Medical Products, Inc.
510(k) numberK911333
Submission
- Device name
- Right Atrial Catheters
- Applicant
- Akcess Medical Products, Inc.
New Brunswick, NJ, US - Received
- March 26, 1991
- Decision date
- September 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K926374 | Silicone Catheter Repair KitsKOC · Traditional | 10/07/1994SESK |
| K925819 | AKCESS0CATH KitLFJ · Traditional | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | 04/05/1994SE |
| K930630 | Right Atrial CatheterLJS · Traditional | 02/07/1994SN |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | 01/14/1994SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | 04/23/1992SESK |
| K920331 | Right Atrial Catheter KitsDQY · Traditional | 04/22/1992SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | 04/10/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | 03/27/1992SESK |
Questions and answers
When was Right Atrial Catheters cleared by the FDA?
Right Atrial Catheters (K911333) received a 510(k) decision of Substantially Equivalent on September 23, 1991, 181 days after the submission was received.
What is the product code of K911333?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.