The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Attachable Cath Lab Hemostasis Valve.
| Device ID | K152528 |
| 510k Number | K152528 |
| Device Name: | Attachable Cath Lab Hemostasis Valve |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | GALT MEDICAL CORP. 2220 MERRITT DR. Garland, TX 75041 |
| Contact | David Derrick |
| Correspondent | David Derrick GALT MEDICAL CORP. 2220 MERRITT DR. Garland, TX 75041 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-12-02 |
| Summary: | summary |