DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
FDA 510(k) clearance K960456 · decided 1996-04-01
Clearance details
- K-number
- K960456
- Device name
- DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
- Applicant
- Denver Biomaterials, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-30
- Decision date
- 1996-04-01
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KDD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Evergreen, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Denver Biomaterials
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.
| Record | Firm | Date |
|---|---|---|
| CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814) | Covidien | 2008-04-16 |
| INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514) | Kencap , Ltd. | 2001-08-13 |
| NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317) | National Healthcare Mfg. Corp. | 1997-05-08 |
| CUSTOM CV PACK (K936255) | Associated Medical | 1994-03-31 |
| SUTURE SET OR LACERATION TRAYS (PACKS) (K932219) | Associated Medical Products Co. | 1993-07-09 |
| SURGICAL INSTRUMENT KIT, DISPOSABLE (K923176) | Ulti-Med Intl., Inc. | 1993-06-17 |
| KIT, SURGICAL INSTRUMENT, DISPOSABLE (K925905) | Kay Medical Concepts | 1993-06-16 |
| BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (K924958) | Medical Insights, Inc. | 1993-06-07 |
| STERILE SURGICAL INSTRUMENT TRAYS (K925215) | American Healthcare Supply Co., Inc. | 1993-06-01 |
| DEXIDE LAPAROSCOPIC KITS (K924117) | Dexide, Inc. | 1993-03-23 |
| SURGICAL INSTRUMENT KIT, DISPOSABLE (K920989) | Ulti-Med Intl., Inc. | 1992-10-19 |
| LACERATTION TRAY (K920763) | Sterile Concepts, Inc. | 1992-09-28 |
Recalls involving this device
No recalls on record reference this clearance.