Submission Details
| 510(k) Number | K930630 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | February 08, 1993 |
| Decision Date | February 07, 1994 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Cleared
Traditional
K930630 - RIGHT ATRIAL CATHETER
(FDA 510(k) Clearance)
Feb 1994
Decision
364d
Days
Class 2
Risk
K930630 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS).
Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 7, 1994, 364 days after receiving the submission on February 8, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
Device Classification
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5970 |
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