ARROW JUGULAR PUNCTURE KIT 16 GA.
FDA 510(k) clearance K820009 · decided 1982-01-22
Clearance details
- K-number
- K820009
- Device name
- ARROW JUGULAR PUNCTURE KIT 16 GA.
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-05
- Decision date
- 1982-01-22
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Arrow Intl.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3 recall (Z-2377-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 In recall (Z-1344-2011) | Arrow International Inc | 2011-02-17 |
| PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture ki recall (Z-1345-2011) | Arrow International Inc | 2011-02-17 |
| VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG. Ves recall (Z-1347-2011) | Arrow International Inc | 2011-02-17 |
| CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central recall (Z-1348-2011) | Arrow International Inc | 2011-02-17 |
| JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit recall (Z-1349-2011) | Arrow International Inc | 2011-02-17 |
| Arrow Single Lumen CVCs (Central Venous Catheters) recall (Z-1494-2009) | Arrow International Inc | 2009-06-24 |