510(k) K073041
- Device
- RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
- Applicant
- ACCLARENT, INC.
- 510(k) number
- K073041
- Product code
- KAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-11
- Date received
- 2007-10-29
- Regulation
- 878.4800
- Classification name
- Cannula, Sinus
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERI YEN
- Address
- 1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025
FDA Registration Numbers#
- 3014334038
- 3023657851
- 3006380247
- 2521453
- 1932180
- 3008936260
- 3003678543
- 3023464160
- 3005575604
- 3011137372
- 9615857
- 1045254
- 3005067367
- 2011171
- 1037007
- 3032391
- 3004001706
- 1928237
- 1836161
- 3002858762
- 8040278
- 2511556
- 3003807268
- 3010041511
- 3007840839
- 3008902714
- 9611827
- 8010298
- 3011050570
- 3015718821
- 3005423519
- 1220850
- 9613926
- 1219795
- 2529846
- 3007597038
- 3018094310
- 1926681
- 3010273872
- 2246990
- 9680718
- 3004608878
- 3005172759
- 3021680161
- 8043368
- 1313525
- 8030607
- 1317188
- 3003418325
- 9610612
- 3008087383
- 2183744
- 3043047788
- 2085947
- 1828288
- 3003790304
Source Documents#
Other 510(k) Records For Product Code KAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | 2011-10-07 |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2010-03-03 |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2009-01-29 |
| K072891 | SINUS SPACER | Acclarent, Inc. | 2008-03-19 |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | 2007-09-28 |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | 2006-09-15 |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | 2006-05-05 |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | 2005-04-27 |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | 2000-02-08 |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | 1997-09-29 |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Atos Medical AB | 1995-02-21 |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | 1993-05-18 |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | Atos Medical AB | 1993-01-21 |
Legacy Summary#
summary
FDA Review#
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