510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Myelotec, Inc.

Mt. Airy, MD, US

Myelotec, Inc. appears in FDA device records in Mt. Airy, MD. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 3 510(k) clearances for Myelotec, Inc. between 1996 and 2013. The busiest year on record is 1996, with 1. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Myelotec, Inc., by decision year
YearClearances
19961
19981
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K122411J-SCOPE SYSTEMHRXSubstantially Equivalent
K980734MYELOTEC VIDEO GUIDED CATHETERHRXSubstantially Equivalent
K960194MYELOTEC MYELOSCOPEHRXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2779-2017Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working ChannelsObstructed/blocked port from defective VGC Access Port Body component.Class IIOpen, Classified
Z-0587-2008Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.Terminated
Z-0586-2008Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain