Identity
- Trade Name
- ApolloTM FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 105-5096-000 APOLLO CATHETER 3.0CM FDA UDI
- Model / Reference
- 105-5096-000 FDA UDI
- Description
- 105-5096-000 APOLLO CATHETER 3.0CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536006041 FDA UDI
- PMA Number
- P030004 FDA UDI
- FDA Product Code
- MFE FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Vascular guide-catheter, single-use
ApolloTM by Micro Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
- Launcher — MEDTRONIC, INC. · Class II
- Launcher™ — MEDTRONIC, INC. · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Cleared under the same submission
P030004 also covers:
- Apollo — Micro Therapeutics, Inc.
- Apollo — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- ApolloTM — Micro Therapeutics, Inc.
- ONYX 18 — Micro Therapeutics, Inc.
- ONYX 34 — Micro Therapeutics, Inc.
- Onyx 18 — Micro Therapeutics, Inc.
- Onyx 34 — Micro Therapeutics, Inc.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI b250b939-cbbb-46de-a44b-0d464b185f67 36 fields · synced May 30, 2026