BT-CATH
Intrauterine Tamponade Balloon
UTAH MEDICAL PRODUCTS, INC.
The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Bt-cath.
Pre-market Notification Details
| Device ID | K101535 |
| 510k Number | K101535 |
| Device Name: | BT-CATH |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Kevin Cornwell |
| Correspondent | Kevin Cornwell UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | OQY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2011-01-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671BTCESY1 | K101535 | 000 |
| H671BTC1001 | K101535 | 000 |
Trademark Results [BT-CATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BT-CATH 76693715 3629206 Live/Registered |
Utah Medical Products, Inc. 2008-10-20 |
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