FDA UDI
In Commercial Distribution
🇺🇸 United States
AtriClip® Flex-V® LAA Exclusion System
DI: 10840143911989
·
Model: ACHV35
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- AtriClip® Flex-V® LAA Exclusion System
- Primary DI
- 10840143911989
- Version / Model
- ACHV35
- Catalog Number
- A001017-4
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-16
- Public Version
- 1
- Public Version Date
- 2024-02-26
- Public Version Status
- New
- Public Device Record Key
- 368efc02-a8e8-4dcb-8065-b895326a09b5
Device Description
LAA Exclusion System, ACHV35
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZX | Left Atrial Appendage Clip, Implantable | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840143911983 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10840143911989 | GS1 | ||||
| Package | 50840143911987 | GS1 | Case | 12 | In Commercial Distribution | |
| Previous | 10840143906541 | GS1 |
Customer Contacts
- Phone
- 866-449-2342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233407 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit