The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Right Atrial Catheter.
| Device ID | K930630 |
| 510k Number | K930630 |
| Device Name: | RIGHT ATRIAL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Contact | Balbir B Kapany |
| Correspondent | Balbir B Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-08 |
| Decision Date | 1994-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787CV332EK0 | K930630 | 000 |