Identity
- Trade Name
- TrapIT FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters. FDA UDI
- Model / Reference
- TRP10015 FDA UDI
- Description
- The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters. FDA UDI
Identifiers
- Catalog Number
- TRP10015 FDA UDI
- Primary DI / UDI-DI
- 08718481740279 FDA UDI
- 510(k) Number
- K191229 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coronary angioplasty balloon catheter, basic
TrapIT by IMDS Operations B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191229 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IMDS Operations B.V.
Sources (1)
- FDA UDI a5c71e2e-5ab3-4292-979b-eb8c7611324d 35 fields · synced May 30, 2026